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Meta-Analysis
. 2005 Apr 18;2005(2):CD003639.
doi: 10.1002/14651858.CD003639.pub2.

Alpha-glucosidase inhibitors for type 2 diabetes mellitus

F A Van de Laar  1 , P L B J Lucassen, R P Akkermans, E H Van de Lisdonk, G E H M Rutten, C Van Weel
Affiliations
Meta-Analysis

Alpha-glucosidase inhibitors for type 2 diabetes mellitus

F A Van de Laar et al. Cochrane Database Syst Rev. .

Abstract

Background: Alpha-glucosidase inhibitors such as acarbose or miglitol, have the potential to improve glycemic control in type 2 diabetes mellitus. The true value of these agents, especially in relation to diabetes related mortality and morbidity, has never been investigated in a systematic literature review and meta-analysis.

Objectives: To assess the effects of alpha-glucosidase inhibitors s in patients with type 2 diabetes mellitus.

Search strategy: We searched The Cochrane Library, MEDLINE, EMBASE, Current Contents, LILACS, databases of ongoing trials, reference lists of reviews on the topic of alpha-glucosidase inhibitors and we contacted experts and manufacturers for additional trials. Date of most recent search: December 2003 (Current Contents) and April 2003 (other databases).

Selection criteria: Randomised controlled trials of at least 12 weeks duration comparing alpha-glucosidase inhibitor monotherapy in patients with type 2 diabetes with any other intervention and that included at least one of the following outcomes: mortality, morbidity, quality of life, glycemic control, lipids, insulin levels, body weight, adverse events.

Data collection and analysis: Two reviewers read all abstracts, assessed quality and extracted data independently. Discrepancies were resolved by consensus or by the judgement of a third reviewer. A statistician checked all extracted data entrance in the database. We attempted to contact all authors for data clarification.

Main results: We included 41 trials (8130 participants), 30 investigated acarbose, seven miglitol, one trial voglibose and three trials compared different alpha-glucosidase inhibitors. Study duration was 24 weeks in most cases and only two studies lasted amply longer than one year. We found only few data on mortality, morbidity and quality of life. Acarbose had a clear effect on glycemic control compared to placebo: glycated haemoglobin -0.8% (95% confidence interval -0.9 to -0.7), fasting blood glucose -1.1 mmol/L (95% confidence interval -1.4 to -0.9), post-load blood glucose -2.3 mmol/L (95% confidence interval -2.7 to -1.9). The effect on glycated haemoglobin by acarbose was not dose-dependent. We found a decreasing effect on post-load insulin and no clinically relevant effects on lipids or body weight. Adverse effects were mostly of gastro-intestinal origin and dose dependent. Compared to sulphonylurea, acarbose decreased fasting and post-load insulin levels by -24.8 pmol/L (95% confidence interval -43.3 to -6.3) and -133.2 pmol/L (95% confidence interval -184.5 to -81.8) respectively and acarbose caused more adverse effects.

Authors' conclusions: It remains unclear whether alpha-glucosidase inhibitors influence mortality or morbidity in patients with type 2 diabetes. Conversely, they have a significant effect on glycemic control and insulin levels, but no statistically significant effect on lipids and body weight. These effects are less sure when alpha-glucosidase inhibitors are used for a longer duration. Acarbose dosages higher than 50 mg TID offer no additional effect on glycated hemoglobin but more adverse effects instead. Compared to sulphonylurea, alpha-glucosidase inhibitors lower fasting and post-load insulin levels and have an inferior profile regarding glycemic control and adverse effects.

PubMed Disclaimer

Conflict of interest statement

FvdL, PL, EvdL, GR and CvW conducted and published a trial that was sponsored by Bayer (Van de Laar 2004a).

Figures

1
1
Flow chart of study selection
2
2
Risk of bias data
1.1
1.1. Analysis
Comparison 1 Acarbose versus placebo, Outcome 1 Change in glycated haemoglobin (%).
1.2
1.2. Analysis
Comparison 1 Acarbose versus placebo, Outcome 2 Change in fasting blood glucose (mmol/l).
1.3
1.3. Analysis
Comparison 1 Acarbose versus placebo, Outcome 3 Change in post‐load blood glucose (mmol/l).
1.4
1.4. Analysis
Comparison 1 Acarbose versus placebo, Outcome 4 Change in total cholesterol (mmol/l).
1.5
1.5. Analysis
Comparison 1 Acarbose versus placebo, Outcome 5 Change in HDL‐cholesterol (mmol/l).
1.6
1.6. Analysis
Comparison 1 Acarbose versus placebo, Outcome 6 Change in LDL‐cholesterol (mmol/l).
1.7
1.7. Analysis
Comparison 1 Acarbose versus placebo, Outcome 7 Change in triglycerides (mmol/l).
1.8
1.8. Analysis
Comparison 1 Acarbose versus placebo, Outcome 8 Change in fasting insulin levels (pmol/l).
1.9
1.9. Analysis
Comparison 1 Acarbose versus placebo, Outcome 9 Change in post‐load insulin levels (pmol/l).
1.10
1.10. Analysis
Comparison 1 Acarbose versus placebo, Outcome 10 Change in fasting C‐peptide levels (nmol/l).
1.11
1.11. Analysis
Comparison 1 Acarbose versus placebo, Outcome 11 Change in post‐load C‐peptide levels (nmol/l).
1.12
1.12. Analysis
Comparison 1 Acarbose versus placebo, Outcome 12 Change in body weight (Kg).
1.13
1.13. Analysis
Comparison 1 Acarbose versus placebo, Outcome 13 Change in body mass index (Kg/m2).
1.14
1.14. Analysis
Comparison 1 Acarbose versus placebo, Outcome 14 Total deaths.
1.15
1.15. Analysis
Comparison 1 Acarbose versus placebo, Outcome 15 Disease related deaths.
1.18
1.18. Analysis
Comparison 1 Acarbose versus placebo, Outcome 18 Occurence of adverse effects.
1.19
1.19. Analysis
Comparison 1 Acarbose versus placebo, Outcome 19 Occurence of gastro‐intestinal adverse effects.
1.21
1.21. Analysis
Comparison 1 Acarbose versus placebo, Outcome 21 Change in post‐load blood glucose (mmol/l) (2‐hours).
1.22
1.22. Analysis
Comparison 1 Acarbose versus placebo, Outcome 22 Change in post‐load insulin levels (pmol/l) (2‐hours).
2.1
2.1. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 1 Change in glycated haemoglobin (%).
2.2
2.2. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 2 Change in fasting blood glucose (mmol/l).
2.3
2.3. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 3 Change in post‐load blood glucose (mmol/l).
2.4
2.4. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 4 Change in total cholesterol (mmol/l).
2.5
2.5. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 5 Change in HDL‐cholesterol (mmol/l).
2.6
2.6. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 6 Change in LDL‐cholesterol (mmol/l).
2.7
2.7. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 7 Change in triglycerides (mmol/l).
2.8
2.8. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 8 Change in fasting insulin levels (pmol/l).
2.9
2.9. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 9 Change in post‐load insulin levels (pmol/l).
2.10
2.10. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 10 Change in fasting C‐peptide levels (nmol/l).
2.11
2.11. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 11 Change in post‐load C‐peptide levels (nmol/l).
2.12
2.12. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 12 Change in body weight (Kg).
2.13
2.13. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 13 Change in body mass index (Kg/m2).
2.14
2.14. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 14 Total deaths.
2.15
2.15. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 15 Disease related deaths.
2.16
2.16. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 16 Occurence of adverse effects.
2.17
2.17. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 17 Occurence of gastro‐intestinal adverse effects.
2.18
2.18. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 18 Change in post‐load blood glucose (mmol/l) (2 hours).
2.19
2.19. Analysis
Comparison 2 Acarbose versus sulphonylurea (SU), Outcome 19 Change in post‐load insulin levels (pmol/l) (2 hours).
3.1
3.1. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 1 Change in glycated haemoglobin (%).
3.2
3.2. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 2 Change in fasting blood glucose (mmol/l).
3.3
3.3. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 3 Change in post‐load blood glucose (mmol/l).
3.4
3.4. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 4 Change in total cholesterol (mmol/l).
3.5
3.5. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 5 Change in HDL‐cholesterol (mmol/l).
3.6
3.6. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 6 Change in LDL‐cholesterol (mmol/l).
3.7
3.7. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 7 Change in triglycerides (mmol/l).
3.8
3.8. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 8 Change in fasting insulin levels (pmol/l).
3.9
3.9. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 9 Change in post‐load insulin levels (pmol/l).
3.10
3.10. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 10 Change in body weight (Kg).
3.11
3.11. Analysis
Comparison 3 Acarbose versus Metformin, Outcome 11 Occurence of adverse effects.
4.1
4.1. Analysis
Comparison 4 Acarbose versus nateglinide / repaglinide, Outcome 1 Change in glycated haemoglobin (%).
4.2
4.2. Analysis
Comparison 4 Acarbose versus nateglinide / repaglinide, Outcome 2 Change in fasting blood glucose (mmol/l).
4.3
4.3. Analysis
Comparison 4 Acarbose versus nateglinide / repaglinide, Outcome 3 Change in body weight (Kg).
4.4
4.4. Analysis
Comparison 4 Acarbose versus nateglinide / repaglinide, Outcome 4 Occurence of adverse effects.
4.5
4.5. Analysis
Comparison 4 Acarbose versus nateglinide / repaglinide, Outcome 5 Occurence of gastro‐intestinal adverse effects.
5.1
5.1. Analysis
Comparison 5 Miglitol versus placebo, Outcome 1 Change in glycated haemoglobin (%).
5.2
5.2. Analysis
Comparison 5 Miglitol versus placebo, Outcome 2 Change in fasting blood glucose (mmol/l).
5.3
5.3. Analysis
Comparison 5 Miglitol versus placebo, Outcome 3 Change in post‐load blood glucose (mmol/l).
5.4
5.4. Analysis
Comparison 5 Miglitol versus placebo, Outcome 4 Change in fasting insulin levels (pmol/l).
5.5
5.5. Analysis
Comparison 5 Miglitol versus placebo, Outcome 5 Change in post‐load insulin levels (pmol/l).
5.6
5.6. Analysis
Comparison 5 Miglitol versus placebo, Outcome 6 Change in body weight (Kg).
5.7
5.7. Analysis
Comparison 5 Miglitol versus placebo, Outcome 7 Total deaths.
5.8
5.8. Analysis
Comparison 5 Miglitol versus placebo, Outcome 8 Disease related deaths.
5.9
5.9. Analysis
Comparison 5 Miglitol versus placebo, Outcome 9 Occurence of adverse effects.
5.10
5.10. Analysis
Comparison 5 Miglitol versus placebo, Outcome 10 Occurence of gastro‐intestinal adverse effects.
5.11
5.11. Analysis
Comparison 5 Miglitol versus placebo, Outcome 11 Change in post‐load blood glucose (mmol/l) (2‐hours).
5.12
5.12. Analysis
Comparison 5 Miglitol versus placebo, Outcome 12 Change in post‐load insulin levels (pmol/l) (2‐hours).
6.1
6.1. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 1 Change in glycated haemoglobin (%).
6.2
6.2. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 2 Change in fasting blood glucose (mmol/l).
6.3
6.3. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 3 Change in post‐load blood glucose (mmol/l).
6.4
6.4. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 4 Change in total cholesterol (mmol/l).
6.5
6.5. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 5 Change in HDL‐cholesterol (mmol/l).
6.6
6.6. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 6 Change in triglycerides (mmol/l).
6.7
6.7. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 7 Change in fasting insulin levels (pmol/l).
6.8
6.8. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 8 Change in body weight (Kg).
6.9
6.9. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 9 Total deaths.
6.10
6.10. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 10 Disease related deaths.
6.11
6.11. Analysis
Comparison 6 Miglitol versus sulphonylurea (SU), Outcome 11 Occurence of adverse effects.
7.1
7.1. Analysis
Comparison 7 Miglitol versus metformin, Outcome 1 Change in glycated haemoglobin (%).
7.2
7.2. Analysis
Comparison 7 Miglitol versus metformin, Outcome 2 Change in fasting blood glucose (mmol/l).
7.3
7.3. Analysis
Comparison 7 Miglitol versus metformin, Outcome 3 Change in post‐load blood glucose (mmol/l).
7.4
7.4. Analysis
Comparison 7 Miglitol versus metformin, Outcome 4 Change in fasting insulin levels (pmol/l).
7.5
7.5. Analysis
Comparison 7 Miglitol versus metformin, Outcome 5 Change in post‐load insulin levels (pmol/l).
7.6
7.6. Analysis
Comparison 7 Miglitol versus metformin, Outcome 6 Change in body weight (Kg).
7.7
7.7. Analysis
Comparison 7 Miglitol versus metformin, Outcome 7 Occurence of gastro‐intestinal side‐effects.
7.8
7.8. Analysis
Comparison 7 Miglitol versus metformin, Outcome 8 Occurence of adverse effects.
7.9
7.9. Analysis
Comparison 7 Miglitol versus metformin, Outcome 9 Change in post‐load blood glucose (mmol/l) (2 hours).
7.10
7.10. Analysis
Comparison 7 Miglitol versus metformin, Outcome 10 Change in post‐load insulin levels (pmol/l) (2‐hours).
8.1
8.1. Analysis
Comparison 8 Voglibose versus placebo, Outcome 1 Change in glycated haemoglobin (%).
8.2
8.2. Analysis
Comparison 8 Voglibose versus placebo, Outcome 2 Change in fasting blood glucose (mmol/l).
8.3
8.3. Analysis
Comparison 8 Voglibose versus placebo, Outcome 3 Change in post‐load blood glucose (mmol/l).
8.4
8.4. Analysis
Comparison 8 Voglibose versus placebo, Outcome 4 Change in post‐load insulin levels (pmol/l).
8.5
8.5. Analysis
Comparison 8 Voglibose versus placebo, Outcome 5 Occurence of adverse effects.
8.6
8.6. Analysis
Comparison 8 Voglibose versus placebo, Outcome 6 Occurence of gastro‐intestinal adverse effects.
8.7
8.7. Analysis
Comparison 8 Voglibose versus placebo, Outcome 7 Change in post‐load blood glucose (mmol/l) (2 hours).
9.1
9.1. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 1 Change in glycated haemoglobin (%).
9.2
9.2. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 2 Change in fasting blood glucose (mmol/l).
9.3
9.3. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 3 Change in total cholesterol (mmol/l).
9.4
9.4. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 4 Change in HDL‐cholesterol (mmol/l).
9.5
9.5. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 5 Change in fasting insulin levels (pmol/l).
9.6
9.6. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 6 Change in body weight (Kg).
9.7
9.7. Analysis
Comparison 9 Voglibose versus diet therapy, Outcome 7 Change in body mass index (Kg/m2).
10.1
10.1. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 1 Change in glycated haemoglobin (%).
10.2
10.2. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 2 Change in fasting blood glucose (mmol/l).
10.3
10.3. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 3 Change in total cholesterol (mmol/l).
10.4
10.4. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 4 Change in HDL‐cholesterol (mmol/l).
10.5
10.5. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 5 Change in fasting insulin levels (pmol/l).
10.6
10.6. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 6 Change in body weight (Kg).
10.7
10.7. Analysis
Comparison 10 .Voglibose versus sulphonylurea (SU), Outcome 7 Change in body mass index (Kg/m2).
11.1
11.1. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 1 Change in glycated haemoglobin (%).
11.2
11.2. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 2 Change in fasting blood glucose (mmol/l).
11.3
11.3. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 3 Change in post‐load blood glucose (mmol/l).
11.4
11.4. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 4 Change in post‐load insulin levels (pmol/l).
11.5
11.5. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 5 Occurence of adverse effects.
11.6
11.6. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 6 Occurence of gastro‐intestinal adverse effects.
11.7
11.7. Analysis
Comparison 11 Miglitol versus voglibose, Outcome 7 Change in post‐load blood glucose (mmol/l) (2 hours).
See this image and copyright information in PMC

Comment in

References

References to studies included in this review

Braun 1996 {published data only}
    1. Braun D, Schonherr U, Mitzkat H‐J. Efficacy of acarbose monotherapy in patients with type 2 diabetes: A double‐blind study conducted in general practice. Endocrinology & Metabolism 1996;3(4):275‐280. [MEDLINE: ]
Buchanan 1988 {published data only}
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Chiasson 2001 {published data only}
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Coniff 1994 {published and unpublished data}
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Coniff 1995 {published and unpublished data}
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Dedov 1995 {published data only}
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Delgado 2002 {published data only}
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Drent 2002 {published and unpublished data}
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    1. Drent ML, Tollefsen AT, Heusden FH, Hoenderdos EB, Jonker JJ, Veen EA. Dose‐dependent efficacy of miglitol, an alpha‐glucosidase inhibitor, in type 2 diabetic patients on diet alone: results of a 24‐week double‐blind placebo‐controlled study. Diabetes, Nutrition & Metabolism 2002;15(3):152‐159. [MEDLINE: ] - PubMed
Fischer 1998 {published and unpublished data}
    1. Fischer S, Hanefeld M, Spengler M, Boehme K, Temelkova‐Kurktschiev T. European study on dose‐response relationship of acarbose as a first‐line drug in non‐insulin‐dependent diabetes mellitus: efficacy and safety of low and high doses. Acta Diabetologica 1998;35(1):34‐40. [MEDLINE: ] - PubMed
Gentile 1999 {published data only}
    1. Gentile S, Turco S, Guarino G, Oliviero B, Rustici A, Torella R. Non‐insulin‐dependent diabetes mellitus associated with nonalcoholic liver cirrhosis: an evaluation of treatment with the intestinal alpha‐glucosidase inhibitor acarbose [Diabete mellito non insulino‐dipendente associato a cirrosi epatica non etilica: valutazione del trattamento con un inhibitore delle alpha‐glucosidasi intestinali, acarbose]. Annali Italiani di Medicina Interna 1999;14(1):7‐14. [MEDLINE: ] - PubMed
    1. Gentile S, Turco S, Persico M, Pananello A, Conte S, Gesuè L, et al. Efficacy of acarbose in the control of diabetes mellitus associated with liver cirrhosis. Journal of Hepatology 1997;26(Suppl 1):S101. [MEDLINE: ]
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Haffner 1997 {published data only}
    1. Fischer S, Patzak A, Rietzsch H, Schwanebeck U, Kohler C, Wildbrett J, et al. Influence of treatment with acarbose or glibenclamide on insulin sensitivity in type 2 diabetic patients. Diabetes, Obesity and Metabolism 2003;5(1):38‐44. [MEDLINE: ] - PubMed
    1. Haffner SM, Hanefeld M, Fischer S, Fucker K, Leonhardt W. Glibenclamide, but not acarbose, increases leptin concentrations parallel to changes in insulin in subjects with NIDDM. Diabetes Care 1997;20(9):1430‐1434. [MEDLINE: ] - PubMed
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Hanefeld 1991 {published and unpublished data}
    1. Hanefeld M, Fischer S, Schulze J, Spengler M, Wargenau M, Schollberg K, et al. Therapeutic potentials of acarbose as first‐line drug in NIDDM insufficiently treated with diet alone. Diabetes Care 1991;14(8):732‐737. [MEDLINE: ] - PubMed
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Hillebrand 1987 {published data only}
    1. Hillebrand I, Englert R. Efficacy and tolerability of a 12‐week treatment with acarbose (BAY g5421), miglitol (BAY m1099) and glibenclamid. Diabetes 1987;26:134A. [MEDLINE: ]
Hoffmann 1990 {published and unpublished data}
    1. Fölsch UR, Spengler M, Boehme K, Sommerauer B. Efficacy of glucosidase inhibitors compared to sulphonylureas in the treatment and metabolic control of diet treated Type II diabetic subjects: Two long‐term comparative studies. Diabetes, Nutrition & Metabolism 1990;3(Suppl. 1):63‐68. [MEDLINE: ]
    1. Hoffmann J. Acarbose and Glibenclamid in Type‐II Diabetes. A Comparative Study on Efficacy and Side Effects [Acarbose und Glibenclamid bei Typ‐II‐Diabetes. Eine Vergleichsstudie zu Wirksamkeit und Nebenwirkungen]. Münchener Medizinische Wochenschrift 1990;132(31‐32):487‐490. [MEDLINE: ]
    1. Hoffmann, J. Adjustment of metabolism and eating behaviour of type II diabetics. Results of a six‐months treatment with glibenclamide, respectively with acarbose [Stoffwechseleinstellung und Essverhalten von Typ‐II‐Diabetikern. Ergebnisse einer sechsmonatigen Behandlung mit Glibenclamid bzw. mit Acarbose]. Zeitschrift für Allgemeinmedizin 1992;68(29):970‐977. [MEDLINE: ]
Hoffmann 1994 {published and unpublished data}
    1. Hoffmann J, Spengler M. Efficacy of 24‐week monotherapy with acarbose, glibenclamide, or placebo in NIDDM patients. The Essen Study. Diabetes Care 1994;17(6):561‐566. [MEDLINE: ] - PubMed
Hoffmann 1997 {published and unpublished data}
    1. Hoffmann J, Spengler M. Efficacy of 24‐week monotherapy with acarbose, metformin, or placebo in dietary‐treated NIDDM patients: the Essen‐II Study. American Journal of Medicine 1997;103(6):483‐490. [MEDLINE: ] - PubMed
Holman 1999 {published and unpublished data}
    1. Holman RR, Cull CA, Turner RC. A randomized double‐blind trial of acarbose in type 2 diabetes shows improved glycemic control over 3 years (U.K. Prospective Diabetes Study 44) [see comments] [published erratum appears in Diabetes Care 1999 Nov;22(11):1922]. Diabetes Care 1999;22(6):960‐4. [MEDLINE: ] - PubMed
Holmes 2001 {published and unpublished data}
    1. Holmes D, Raccah D, Escobar‐Jimenez F, Standl E. Targeting postprandial hyperglycemia in patients with type 2 diabetes: nateglinide vs acarbose. Diabetologia 2001;44(Suppl 1):A215. [MEDLINE: ]
    1. Holmes D, Raccah D, Escobar‐Jimenez F, Standl E. Targeting postprandial hyperglycemia to achieve glycemic control in patients with type 2 diabetes: a comparison of nateglinide and acarbose [Poster presentation]. EASD Congress 9‐13 september 2001, Glasgow (UK). [MEDLINE: ]
    1. Raccah D, Escobar‐Jimenez F, Gomis R, Holmes D, Standl E. Targeting prandial glucose with nateglinide and acarbose in the treatment of type 2 diabetes: a double‐blind clinical comparison. Unpublished Document. [MEDLINE: ]
Hotta 1993 {published and unpublished data}
    1. Hotta N, Kakuta H, Sano T, Matsumae H, Yamada H, Kitazawa S, et al. Long‐term effect of acarbose on glycaemic control in non‐insulin‐dependent diabetes mellitus: a placebo‐controlled double‐blind study. Diabetic Medicine 1993;10(2):134‐138. [MEDLINE: ] - PubMed
    1. Sakamoto N, Hotta N, Kakuta H, Sano T, Yamada H, Matsumae H, et al. An investigation into the efficacy of long term usage of Bay g 5421 (acarbose) for non‐insulin dependent diabetes. A placebo controlled, double blind trial [japanese]. Rinshou to Kenkyu 1990;67(1):219‐233. [MEDLINE: ]
Johnston 1998 {published data only}
    1. Johnston PS, Lebovitz HE, Coniff RF, Simonson DC, Raskin P, Munera CL. Advantages of alpha‐glucosidase inhibition as monotherapy in elderly type 2 diabetic patients. The Journal of Clinical Endocrinology and Metabolism 1998;83(5):1515‐1522. [MEDLINE: ] - PubMed
Johnston 1998a {published data only}
    1. Johnston PS, Feig PU, Coniff RF, Krol A, Davidson JA, Haffner SM. Long‐term titrated‐dose alpha‐glucosidase inhibition in non‐insulin‐requiring Hispanic NIDDM patients. Diabetes Care 1998;21(3):409‐415. [MEDLINE: ] - PubMed
Johnston 1998b {published data only}
    1. Johnston PS, Feig PU, Coniff RF, Krol A, Kelley DE, Mooradian AD. Chronic treatment of African‐American type 2 diabetic patients with alpha‐glucosidase inhibition. Diabetes Care 1998;21(3):416‐422. [MEDLINE: ] - PubMed
Kawamori 2003 {published data only}
    1. Kawamori R, Toyota T, Oka Y, Yamada A, Iwamoto Y, Tajima N, et al. Improvement of glycaemic control following 12‐week treatment with miglitol in Japanese type 2 diabetics: a double‐blind, randomized, placebo‐ and voglibose‐controlled trial. Poster display, IDF Congress Paris august 25 2003. [MEDLINE: ]
Kovacevic 1997 {published and unpublished data}
    1. Kovacevic I, Profozic V, Skrabalo Z, Cabrijan T, Zjacic‐Rotkvic V, Goldoni V, et al. Multicentric clinical trial to assess efficacy and tolerability of acarbose (BAY G 5421) in comparison to glibenclamide and placebo. Diabetologia Croatica 1997;26(2):83‐89. [MEDLINE: ]
Meneilly 2000 {published data only}
    1. Josse RG, Chiasson JL, Ryan EA, Lau DC, Ross SA, Yale JF, et al. Acarbose in the treatment of elderly patients with type 2 diabetes. Diabetes Research and Clinical Practice 2003;59(1):37‐42. [MEDLINE: ] - PubMed
    1. Meneilly GS, Ryan EA, Radziuk J, Lau DC, Yale JF, Morais J, et al. Effect of acarbose on insulin sensitivity in elderly patients with diabetes. Diabetes Care 2000;23(8):1162‐1167. [MEDLINE: ] - PubMed
Pagano 1995 {published and unpublished data}
    1. Marena S, Pagani A, Montegrosso G, Boella G, Pagano A, Michieli F, et al. Comparison of miglitol and glibenclamide in non insulin‐dependent diabetic patients. [Italian]. Giornale Italiano di Diabetologia 1993;13(4):383‐388. [MEDLINE: ]
    1. Marena S, Pagani A, Montegrosso G, Boella G, Pagano A, Michieli F, et al. Miglitol vs Glibenclamide in non‐insulin dependent diabete mellitus. European Journal of Clinical Investigation 1993;23(Suppl 1):A43. [MEDLINE: ]
    1. Pagano G, Marena S, Corgiat‐Mansin L, Cravero F, Giorda C, Bozza M, et al. Comparison of miglitol and glibenclamide in diet‐treated type 2 diabetic patients. Diabete & Metabolisme 1995;21(3):162‐167. [MEDLINE: ] - PubMed
Rosenthal 2002 {published and unpublished data}
    1. Mauersberger H, Rosenthal JH. Wirkung von endogenem Insulin sowie Acarbose oder Glibenclamide in der Therapie der Hypertonie bei Typ‐2‐Diabetikern. CF‐Journal 2001, (1):26‐28. [MEDLINE: ]
    1. Rosenthal JH, Mauersberger H. Effects on blood pressure of the alpha‐glucosidase inhibitor acarbose compared with the insulin enhancer glibenclamide in patients with hypertension and type 2 diabetes mellitus. Clinical Drug Investigation 2002;22(10):695‐701. [MEDLINE: ]
    1. Rosenthal JH, Mauersberger H. Hypertension in type 2‐diabetic patients ‐ Effects of endogenous insulin and antidiabetic therapies. American Journal of Hypertension 2000;13(4 Suppl 1):S81. [MEDLINE: ]
Rybka 1999 {published data only}
    1. Bayer Vital GmbH, Company K.H. Efficacy and tolerability of miglitol (Bay m 1099) and acarbose (Bay g 5421) in type II diabetes, Report no: R6245 (Data on File). 1994. [MEDLINE: ]
    1. Rybka J, Goke B, Sissmann J. European comparative study of 2 alpha‐glucosidase inhibitors, miglitol and acarbose. Diabetes 1999;48(Suppl. 1):101. [MEDLINE: ]
Salman 2001 {published and unpublished data}
    1. Salman S, Salman F, Satman I, Yilmaz Y, Ozer E, Sengul A, et al. Comparison of acarbose and gliclazide as first‐line agents in patients with type 2 diabetes. Current Medical Research and Opinion. 2001;16(4):296‐306. [MEDLINE: ] - PubMed
Santeusanio 1993 {published and unpublished data}
    1. Santeusanio F, Ventura MM, Contadini S, Compagnucci P, Moriconi V, Zaccarini P, et al. Efficacy and safety of two different dosages of acarbose in non‐insulin dependent diabetic patients treated by diet alone. Diabetes, Nutrition & Metabolism ‐ Clinical & Experimental 1993;6(3):147‐154. [MEDLINE: ]
Scott 1999 {published and unpublished data}
    1. Scott R, Lintott CJ, Zimmet P, Campbell L, Bowen K, Welborn T. Will acarbose improve the metabolic abnormalities of insulin‐resistant type 2 diabetes mellitus?. Diabetes Research and Clinical Practice 1999;43(3):179‐185. [MEDLINE: ] - PubMed
Segal 1997 {published data only}
    1. Segal P, Feig PU, Schernthaner G, Ratzmann KP, Rybka J, Petzinna D, et al. The efficacy and safety of miglitol therapy compared with glibenclamide in patients with NIDDM inadequately controlled by diet alone. Diabetes Care 1997;20(5):687‐691. [MEDLINE: ] - PubMed
Spengler 1992 {published and unpublished data}
    1. Fölsch UR, Spengler M, Boehme K, Sommerauer B. Efficacy of glucosidase inhibitors compared to sulphonylureas in the treatment and metabolic control of diet treated Type II diabetic subjects: Two long‐term comparative studies. Diabetes, Nutrition & Metabolism 1990;3(Suppl. 1):63‐68. [MEDLINE: ]
    1. Spengler M, Hansel G, Boehme K. 6 Months monotherapy of NIDDM with acarbose or glibenclamide. New Aspects in Diabetes. Treatment Strategies with Alpha‐Glucosidase Inhibitors. Third International Symposium on Acarbose. Berlin ‐ New York: Walter de Gruyter, 1992:243‐6. [MEDLINE: ]
    1. Spengler M, Hansel G, Boehme K. Efficacy of 6 months monotherapy with glucosidase inhibitor acarbose versus sulphonylurea glibenclamide on metabolic control of dietary treated type II diabetics (NIDDM). Hormone & Metabolic Research 1992, (Supp 26):50‐51. [MEDLINE: ] - PubMed
    1. Spengler M, Hänsel G, Boehme K. Efficacy of 6 months monotherapy with glucosidase inhibitor acarbose versus sulphonylurea glibenclamid on metabolic control of dietary treated type II diabetics. European Journal of Clinical Investigation. 1989; Vol. 19, issue 2 part II:A71. [MEDLINE: ] - PubMed
    1. Spengler M, Hänsel, M, Boehme, K. Acarbose and glibenclamide in type II diabetes [Acarbose und Glibenclamid bei Typ‐II‐Diabetes]. Zeitschrift für Allgemeinmedizin 1990;65(22):606‐610. [MEDLINE: ]
Takami 2002 {published data only}
    1. Takami K, Takeda N, Nakashima K, Takami R, Hayashi M, Ozeki S, et al. Effects of dietary treatment alone or diet with voglibose or glyburide on abdominal adipose tissue and metabolic abnormalities in patients with newly diagnosed type 2 diabetes. Diabetes Care 2002;25(4):658‐662. [MEDLINE: ] - PubMed
Van de Laar 2004a {published and unpublished data}
    1. Laar FA, Lucassen PLBJ, Kemp J, Lisdonk EH, Weel C, Rutten GEHM. Is acarbose equivalent to tolbutamide as first treatment for newly diagnosed diabetes in general practice? A randomised controlled trial. Diabetes Research and Clinical Practice 2004;63(1):57‐65. [MEDLINE: ] - PubMed
Zheng 1995 {published data only}
    1. Zheng GF, Wang JP, Zhang H, Hu ZX, Liu J, Xiao JZ, et al. Clinical observation on glucobay treatment for NIDDM. [Chinese]. Chinese Journal of Endocrinology 1995;11(3):163‐164. [MEDLINE: ]

References to studies excluded from this review

Bachmann 2003 {published data only}
    1. Bachmann W, Petzinna D, Sotiros A, Wascher T. Long‐Term Improvement of Metabolic Control by Acarbose in Type 2 Diabetes Patients Poorly Controlled with Maximum Sulfonylurea Therapy. Clinical Drug Investigation 2003;23(10):679‐686. [MEDLINE: ] - PubMed
Bayer 2003 {unpublished data only}
    1. Bayer AG. Study No. 541. Data on file, Bayer. [MEDLINE: ]
Bayer 2003a {unpublished data only}
    1. Bayer AG. Study No. 656. Data on file, Bayer. [MEDLINE: ]
Coniff 1995a {published data only}
    1. Coniff RF, Shapiro JA, Seaton TB, Hoogwerf BJ, Hunt JA. A double‐blind placebo‐controlled trial evaluating the safety and efficacy of acarbose for the treatment of patients with insulin‐requiring type II diabetes. Diabetes Care 1995;18(7):928‐932. [MEDLINE: ] - PubMed
De Leiva 1993 {published data only}
    1. Leiva A, Piñón F, Tébar J, Escobar‐Jiménez F, Calle H, Herrera‐Pombo JL, et al. Clinical efficacy and tolerance to acarbose in the treatment of non‐insulin‐dependent diabetic patients [Eficacia clínica y tolerancia de la acarbosa en el tratamiento de pacientes diabéticos no dependientes de la insulina (tipo II)]. Medicina clinica 1993;100(10):368‐371. [MEDLINE: ] - PubMed
Escobar‐Jimenez 1995 {published data only}
    1. Escobar‐Jimenez F, Barajas C, Leiva A, Cano FJ, Masoliver R, Herrera‐Pombo JL, et al. Efficacy and tolerability of miglitol in the treatment of patients with non‐insulin‐dependent diabetes mellitus. Current Therapeutic Research, Clinical & Experimental 1995;56(3):258‐268. [MEDLINE: ]
Fujita 2001 {published data only}
    1. Fujita H, Yamagamu T, Ahshima K. Long‐term ingestion of a fermented soybean‐derived Touchi‐extract with alpha‐glucosidase inhibitory activity is safe and effective in humans with borderline and mild type‐2 diabetes. Journal of Nutrition 2001;131(8):2105‐2108. [MEDLINE: ] - PubMed
Hasche 1999 {published data only}
    1. Hasche H, Mertes G, Bruns C, Englert R, Genthner P, Heim D, et al. Effects of acarbose treatment in Type 2 diabetic patients under dietary training: a multicentre, double‐blind, placebo‐controlled, 2‐year study. Diabetes, Nutrition & Metabolism 1999;12(4):277‐285. [MEDLINE: ] - PubMed
Holman 1991 {published data only}
    1. Holman RR, Steemson J, Turner RC. Post‐prandial glycaemic reduction by an alpha‐glucosidase inhibitor in type 2 diabetic patients with therapeutically attained basal normoglycaemia. Diabetes Research (Edinburgh, Lothian) 1991;18(4):149‐153. [MEDLINE: ] - PubMed
Ikeda 1998 {published data only}
    1. Ikeda T, Murao A, Santou Y, Murakami H, Yamamoto R. Comparison of the clinical effect of acarbose and voglibose on blood glucose in non‐obese, non‐insulin dependent diabetes mellitus [Japanese]. Therapeutic Research 1998;19(9):271‐278. [MEDLINE: ]
Jenney 1993 {published data only}
    1. Jenney A, Proietto J, O'Dea K, Nankervis A, Traianedes K, D'Embden H. Low‐dose acarbose improves glycemic control in NIDDM patients without changes in insulin sensitivity. Diabetes Care 1993;16(2):499‐502. [MEDLINE: ] - PubMed
Rosak 2002 {published data only}
    1. Rosak C, Haupt E, Walter T, Werner J. The effect of combination treatment with acarbose and glibenclamide on postprandial glucose and insulin profiles: additive blood glucose lowering effect and decreased hypoglycaemia. Diabetes, Nutrition & Metabolism 2002;15(3):143‐151. [MEDLINE: ] - PubMed
Rosenbaum 2002 {published data only}
    1. Rosenbaum P, Peres RB, Zanella MT, Ferreira SRG. Improved glycemic control by acarbose therapy in hypertensive diabetic patients: effects on blood pressure and hormonal parameters. Brazilian Journal of Medical and Biological Research 2002;35(8):877‐884. [MEDLINE: ] - PubMed
Soonthornpun 1998 {published data only}
    1. Soonthornpun S, Rattarasarn C, Thamprasit A, Leetanaporn K. Effect of acarbose in treatment of type II diabetes mellitus: a double‐blind, crossover, placebo‐controlled trial. Journal of the Medical Association of Thailand 1998;81(3):195‐200. [MEDLINE: ] - PubMed
Wang 2000 {published data only}
    1. Wang H, Xu WH, Wang GY. An evalualion on efficacy of acarbose interfering treatment on IGT. Shanxi Clinical Medicine Journal 2000;9(2):116‐117. [MEDLINE: ]

References to ongoing studies

Holman 2003 {published data only}
    1. Holman R. Early Diabetes Intervention Study (EDIT). The National Research Register 2003, issue 1. [N0162013485]
Sa‐adu 2003 {published data only}
    1. Sa‐adu A. A one‐year multicentre, international, randomised, double‐blind comparison of Mitiglinide (10to40mgTID) and Acarbose (50mgODto100mgTID) administered orally for the treatment of elderly type 2 diabetic patients. The National Research Register 2003, issue 1. [N0235102775]
Whitby 1998 {published data only}
    1. Ryder REJ. BIOS ‐ A long‐term study to investigate the effects of acarbose (Glucobay) in preventing or delaying deterioration in glycaemic status in non‐insulin dependent diabetes well controlled on diet alone. The National Research Register 2003, issue 1. [N0064018154]
    1. Whitby RJ. A long‐term study to investigate the effects of acarbose (glucobay) in preventing or delaying deterioration in glycaemic status in non‐insulin diabetes well controlled on diet alone. The National Research Register 2003, issue 1:Publication ID: B0201167. [Publication ID: B0201167]

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References to other published versions of this review

Van de Laar 2005
    1. Laar FA, Lucassen PL, Akkermans RP, Lisdonk EH, Rutten GE, Weel C. Alpha‐glucosidase inhibitors for patients with type 2 diabetes. Results from a Cochrane systematic review and meta‐analysis.. Diabetes Care 2005;28(1):154‐163. - PubMed

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