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. 2017 May 10;5(5):CD012204.
doi: 10.1002/14651858.CD012204.pub2.

Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus

Bianca Hemmingsen  1 , David P Sonne  2 , Maria-Inti Metzendorf  3 , Bernd Richter  3
Affiliations

Dipeptidyl-peptidase (DPP)-4 inhibitors and glucagon-like peptide (GLP)-1 analogues for prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus

Bianca Hemmingsen et al. Cochrane Database Syst Rev. .

Abstract

Background: The projected rise in the incidence of type 2 diabetes mellitus (T2DM) could develop into a substantial health problem worldwide. Whether dipeptidyl-peptidase (DPP)-4 inhibitors or glucagon-like peptide (GLP)-1 analogues are able to prevent or delay T2DM and its associated complications in people at risk for the development of T2DM is unknown.

Objectives: To assess the effects of DPP-4 inhibitors and GLP-1 analogues on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose, moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.

Search methods: We searched the Cochrane Central Register of Controlled Trials; MEDLINE; PubMed; Embase; ClinicalTrials.gov; the World Health Organization (WHO) International Clinical Trials Registry Platform; and the reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of the included trials for information about additional trials. The date of the last search of all databases was January 2017.

Selection criteria: We included randomised controlled trials (RCTs) with a duration of 12 weeks or more comparing DPP-4 inhibitors and GLP-1 analogues with any pharmacological glucose-lowering intervention, behaviour-changing intervention, placebo or no intervention in people with impaired fasting glucose, impaired glucose tolerance, moderately elevated HbA1c or combinations of these.

Data collection and analysis: Two review authors read all abstracts and full-text articles and records, assessed quality and extracted outcome data independently. One review author extracted data which were checked by a second review author. We resolved discrepancies by consensus or the involvement of a third review author. For meta-analyses, we planned to use a random-effects model with investigation of risk ratios (RRs) for dichotomous outcomes and mean differences (MDs) for continuous outcomes, using 95% confidence intervals (CIs) for effect estimates. We assessed the overall quality of the evidence using the GRADE instrument.

Main results: We included seven completed RCTs; about 98 participants were randomised to a DPP-4 inhibitor as monotherapy and 1620 participants were randomised to a GLP-1 analogue as monotherapy. Two trials investigated a DPP-4 inhibitor and five trials investigated a GLP-1 analogue. A total of 924 participants with data on allocation to control groups were randomised to a comparator group; 889 participants were randomised to placebo and 33 participants to metformin monotherapy. One RCT of liraglutide contributed 85% of all participants. The duration of the intervention varied from 12 weeks to 160 weeks. We judged none of the included trials at low risk of bias for all 'Risk of bias' domains and did not perform meta-analyses because there were not enough trials.One trial comparing the DPP-4 inhibitor vildagliptin with placebo reported no deaths (very low-quality evidence). The incidence of T2DM by means of WHO diagnostic criteria in this trial was 3/90 participants randomised to vildagliptin versus 1/89 participants randomised to placebo (very low-quality evidence). Also, 1/90 participants on vildagliptin versus 2/89 participants on placebo experienced a serious adverse event (very low-quality evidence). One out of 90 participants experienced congestive heart failure in the vildagliptin group versus none in the placebo group (very low-quality evidence). There were no data on non-fatal myocardial infarction, stroke, health-related quality of life or socioeconomic effects reported.All-cause and cardiovascular mortality following treatment with GLP-1 analogues were rarely reported; one trial of exenatide reported that no participant died. Another trial of liraglutide 3.0 mg showed that 2/1501 in the liraglutide group versus 2/747 in the placebo group died after 160 weeks of treatment (very low-quality evidence).The incidence of T2DM following treatment with liraglutide 3.0 mg compared to placebo after 160 weeks was 26/1472 (1.8%) participants randomised to liraglutide versus 46/738 (6.2%) participants randomised to placebo (very low-quality evidence). The trial established the risk for (diagnosis of) T2DM as HbA1c 5.7% to 6.4% (6.5% or greater), fasting plasma glucose 5.6 mmol/L or greater to 6.9 mmol/L or less (7.0 mmol/L or greater) or two-hour post-load plasma glucose 7.8 mmol/L or greater to 11.0 mmol/L (11.1 mmol/L). Altogether, 70/1472 (66%) participants regressed from intermediate hyperglycaemia to normoglycaemia compared with 268/738 (36%) participants in the placebo group. The incidence of T2DM after the 12-week off-treatment extension period (i.e. after 172 weeks) showed that five additional participants were diagnosed T2DM in the liraglutide group, compared with one participant in the placebo group. After 12-week treatment cessation, 740/1472 (50%) participants in the liraglutide group compared with 263/738 (36%) participants in the placebo group had normoglycaemia.One trial used exenatide and 2/17 participants randomised to exenatide versus 1/16 participants randomised to placebo developed T2DM (very low-quality evidence). This trial did not provide a definition of T2DM. One trial reported serious adverse events in 230/1524 (15.1%) participants in the liraglutide 3.0 mg arm versus 96/755 (12.7%) participants in the placebo arm (very low quality evidence). There were no serious adverse events in the trial using exenatide. Non-fatal myocardial infarction was reported in 1/1524 participants in the liraglutide arm and in 0/55 participants in the placebo arm at 172 weeks (very low-quality evidence). One trial reported congestive heart failure in 1/1524 participants in the liraglutide arm and in 1/755 participants in the placebo arm (very low-quality evidence). Participants receiving liraglutide compared with placebo had a small mean improvement in the physical component of the 36-item Short Form scale showing a difference of 0.87 points (95% CI 0.17 to 1.58; P = 0.02; 1 trial; 1791 participants; very low-quality evidence). No trial evaluating GLP-1-analogues reported data on stroke, microvascular complications or socioeconomic effects.

Authors' conclusions: There is no firm evidence that DPP-4 inhibitors or GLP-1 analogues compared mainly with placebo substantially influence the risk of T2DM and especially its associated complications in people at increased risk for the development of T2DM. Most trials did not investigate patient-important outcomes.

PubMed Disclaimer

Conflict of interest statement

BH: this review is part of a series of reviews on interventions for the prevention or delay of type 2 diabetes mellitus and its associated complications in people at increased risk for the development of type 2 diabetes mellitus, which is funded by the World Health Organization (Hemmingsen 2016a; Hemmingsen 2016b; Hemmingsen 2016c).

DS: none known.

MIM: none known.

BR: none known.

Figures

1
1
Study flow diagram.
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included trials (blank cells indicate that the particular outcome was not measured in some trials).
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included trial (blank cells indicate that the particular outcome was not measured in some trials).
1.1
1.1. Analysis
Comparison 1 Dipeptidyl‐peptidase (DPP)‐4 inhibitors versus metformin, Outcome 1 Non‐serious adverse events.
1.2
1.2. Analysis
Comparison 1 Dipeptidyl‐peptidase (DPP)‐4 inhibitors versus metformin, Outcome 2 Fasting blood glucose.
1.3
1.3. Analysis
Comparison 1 Dipeptidyl‐peptidase (DPP)‐4 inhibitors versus metformin, Outcome 3 2‐hour glucose.
1.4
1.4. Analysis
Comparison 1 Dipeptidyl‐peptidase (DPP)‐4 inhibitors versus metformin, Outcome 4 Haemoglobin A1c.
2.1
2.1. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 1 Incidence of type 2 diabetes mellitus.
2.2
2.2. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 2 Serious adverse events.
2.3
2.3. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 3 Congestive heart failure.
2.4
2.4. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 4 Non‐serious adverse events.
2.5
2.5. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 5 Fasting glucose.
2.6
2.6. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 6 2‐hour glucose values.
2.7
2.7. Analysis
Comparison 2 DDP‐4 inhibitors versus placebo, Outcome 7 Haemoglobin A1c.
3.1
3.1. Analysis
Comparison 3 Glucagon‐like peptide (GLP)‐1 analogues versus metformin, Outcome 1 Fasting blood glucose.
4.1
4.1. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 1 Incidence of type 2 diabetes mellitus.
4.2
4.2. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 2 Serious adverse events.
4.3
4.3. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 3 Non‐serious adverse events.
4.4
4.4. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 4 Mild hypoglycaemia.
4.5
4.5. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 5 Fasting blood glucose.
4.6
4.6. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 6 2‐hour glucose.
4.7
4.7. Analysis
Comparison 4 Glucagon‐like peptide (GLP)‐1 analogues versus placebo, Outcome 7 Haemoglobin A1c.
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NCT00198146 {published data only}
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    1. NCT01006018. DPP‐4 Inhibition and TZD for DM Prevention (DInT DM). clinicaltrials.gov/ct2/show/NCT01006018 Date first received: 27 October 2009.
NCT01018602 {published data only}
    1. NCT01018602. PINGUIN (Postpartum Intervention in Women with Gestational Diabetes Using Insulin). clinicaltrials.gov/ct2/show/NCT01018602 Date first received: 20 November 2009.
NCT01038648 {published and unpublished data}
    1. NCT01038648. Sitagliptin in Prevention of Type 2 Diabetes Mellitus (SITAGLIPTIN). clinicaltrials.gov/ct2/show/NCT01038648 Date first received: 22 December 2009.
NCT01054118 {published data only}
    1. NCT01054118. A study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single doses of JNJ‐38431055, sitagliptin, and co‐administration of JNJ‐38431055 and sitagliptin. clinicaltrials.gov/ct2/show/NCT01054118 Date first received: 15 January 2010.
NCT01122641 {published data only}
    1. NCT01122641. The vascular effects of vildagliptin in insulin resistant individuals. clinicaltrials.gov/ct2/show/NCT01122641 Date first received: 12 May 2010.
NCT01346254 {published data only}
    1. NCT01346254. Glucose control in pre‐diabetic renal transplant patients (GCPD). clinicaltrials.gov/ct2/show/NCT01346254 Date first received: 29 April 2011.
NCT01472640 {published data only}
    1. NCT01472640. The effect of liraglutide on left ventricular function in chronic heart failure patients with and without type 2 diabetes mellitus. clinicaltrials.gov/ct2/show/NCT01472640 Date first received: 11 November 2011.
NCT01845259 {published data only}
    1. NCT01845259. Does a GLP‐1 receptor agonist change glucose tolerance in antipsychotic‐treated patients? (GREAT). clinicaltrials.gov/ct2/show/NCT01845259 Date first received: 14 April 2013.
NCT01970462 {published data only}
    1. NCT01970462. Use of sitagliptin for stress hyperglycemia or mild diabetes following cardiac surgery. clinicaltrials.gov/ct2/show/NCT01970462 Date first received: 22 October 2013.
NCT02016846 {published data only}
    1. NCT02016846. Liraglutide efficacy on glucocorticoid induced hyperglycemia in patients high risk for diabetes. clinicaltrials.gov/ct2/show/NCT02016846 Date first received: 15 December 2013.
NCT02022007 {published data only}
    1. NCT02022007. Saxagliptin + metformin compared to saxagliptin or metformin monotherapy in PCOS women Wwith impaired glucose homeostasis (BMS‐AZPCOS). clinicaltrials.gov/ct2/show/NCT02022007 Date first received: 17 December 2013. [NCT02022007]
NCT02284230 {published data only}
    1. 2014‐001778‐32/DK. The LiRA2 study. www.clinicaltrialsregister.eu/ctr‐search/trial/2014‐001778‐32/DK Date first registered: 17 June 2014.
    1. NCT02284230. The effect of liraglutide in patients with prediabetes and kidney failure (LiRA2). clinicaltrials.gov/ct2/show/NCT02284230 Date first received: 3 November 2014.
NCT02446834 {published data only}
    1. NCT02446834. Research of intensive lifestyle Intervention for PCOS patients with IGT. clinicaltrials.gov/ct2/show/NCT02446834 Date first received: 6 May 2015.
Schwartz 2010 {published data only}
    1. Koska J, Sands M, Burciu C, D'Souza KM, Raravikar K, Liu J, et al. Exenatide protects against glucose‐ and lipid‐induced endothelial dysfunction: evidence for direct vasodilation effect of GLP‐1 receptor agonists in humans. Diabetes 2015;64(7):2624‐35. [PUBMED: 25720388] - PMC - PubMed
    1. Koska J, Schwartz EA, Mullin MP, Schwenke DC, Reaven PD. Improvement of postprandial endothelial function after a single dose of exenatide in individuals with impaired glucose tolerance and recent‐onset type 2 diabetes. Diabetes Care 2010;33(5):1028‐30. [PUBMED: 20200309] - PMC - PubMed
    1. Mullin MP, Koska J, Schwartz EA, Schwenke DC, Reaven PD. Acute administration of exenatide improves endothelial function following a high‐fat meal. Diabetes 2009;58:P‐640.
    1. Schwartz EA, Koska J, Mullin MP, Schwenke DC, Reaven PD. Effects of acute exenatide administration on postprandial lipids and lipoproteins in individuals with impaired glucose metabolism. Diabetes 2009; Vol. 58:375‐OR.
    1. Schwartz EA, Koska J, Mullin MP, Syoufi I, Schwenke DC, Reaven PD. Exenatide suppresses postprandial elevations in lipids and lipoproteins in individuals with impaired glucose tolerance and recent onset type 2 diabetes mellitus. Atherosclerosis 2010;212(1):217‐22. [PUBMED: 20557887] - PubMed
Tsuchiya 2011 {published data only}
    1. Aramaki M. Alogliptin, but not voglibose, ameliorates dyslipidemia and LDL particle size in patients with impaired glucose tolerance or Type 2 diabetes. Clinical Lipidology 2013;8(5):533‐40.
    1. Tsuchiya M. Alogliptin ameliorates dyslipidemia and LDL‐size in patients with IGT or type 2 diabetes: comparing alogliptin and voglibose. Diabetes 2011;60:A280.
    1. Tsuchiya M. Alogliptin decreases liver fat content in patients with IGT or type Q2 DM: comparing alogliptin and voglibose. Diabetes 2011;60:A595.
    1. Tsuchiya M, Maegawa H. DPP4 inhibition ameliorates intramuscular fat content in patients with IGT or type 2 DM: comparing alogliptin and voglibose. Diabetes 2013;62:A297.
UMIN000006197 {published data only}
    1. UMIN000006197. Therapeutic efficacy of sitagliptin in patients with nonalcoholic fatty liver disease (NAFLD) in impaired glucose tolerance (IGT): a pilot study. upload.umin.ac.jp/cgi‐open‐bin/ctr/ctr.cgi?function=brows&action=bro... Date first registered: 1 September 2011.
UMIN000014249 {published data only}
    1. UMIN000014249. Efficacy and safety of combination therapy with GLP‐1 analog lixisenatide and long‐acting insulin glargine in patients with glucose intolerance or diabetes caused by hyposecretion of endogenous insulin who underwent partial pancreatectomy. upload.umin.ac.jp/cgi‐open‐bin/ctr/ctr.cgi?function=brows&action=bro... Date first registered: 12 June 2014.
Utzschneider 2008 {published data only}
    1. NCT00312130. A study to evaluate the effects of vildagliptin on the insulin response to glucose in subjects with pre‐diabetes. clinicaltrials.gov/ct2/show/NCT00312130 Date first received: 6 April 2006.
    1. Utzschneider KM, Tong J, Montgomery B, Udayasankar J, Gerchman F, Marcovina SM, et al. The dipeptidyl peptidase‐4 inhibitor vildagliptin improves beta‐cell function and insulin sensitivity in subjects with impaired fasting glucose. Diabetes Care 2008;31(1):108‐13. [PUBMED: 17909087] - PubMed
Werzowa 2013 {published data only}
    1. Werzowa J, Hecking M, Haidinger M, Lechner F, Doller D, Pacini G, et al. Vildagliptin and pioglitazone in patients with impaired glucose tolerance after kidney transplantation: a randomized, placebo‐controlled clinical trial. Transplantation 2013;95(3):456‐62. [PUBMED: 23380864] - PubMed

References to studies awaiting assessment

Astrup 2009 {published data only}
    1. Astrup A, Carraro R, Finer N, Harper A, Kunesova M, Lean ME, et al. Safety, tolerability and sustained weight loss over 2 years with the once‐daily human GLP‐1 analog, liraglutide. International Journal of Obesity (2005) 2012;36(6):843‐54. [PUBMED: 21844879] - PMC - PubMed
    1. Astrup A, Rossner S, Gaal L, Rissanen A, Niskanen L, Al Hakim M, et al. Effects of liraglutide in the treatment of obesity: a randomised, double‐blind, placebo‐controlled study. Lancet 2009;374(9701):1606‐16. [PUBMED: 19853906] - PubMed
    1. EudraCT 2006‐004481‐13. Effect of liraglutide on body weight in obese subjects without diabetes. A 20‐week randomised, double‐blind, placebo‐controlled, six armed parallel group, multi‐centre, multinational trial with an open label orlistat comparator arm with an 84 week extension period. www.clinicaltrialsregister.eu/ctr‐search/trial/2006‐004481‐13/DK Date first received: 3 October 2006.
    1. Finer N, Astrup A, Carraro R, Hartvig H, Kunesova M, Lean ME, et al. Liraglutide once daily reduces the prevalence of prediabetes and metabolic syndrome in obese non‐diabetic adults over two years. Journal of Diabetes 2011;3:30.
    1. Finer N, Hakim MA, Astrup A, Harper A, Lean M, Niskanen L, et al. Liraglutide, a once‐daily human GLP‐1 analog, reverses indices of prediabetes in obese subjects: a randomized placebo‐controlled 20‐week trial. Diabetes 2009;58.
NCT01521312 {published data only}
    1. NCT01521312. Acute and chronic effects of saxagliptin (ACCES). clinicaltrials.gov/ct2/show/NCT01521312 Date first received: 22 November 2011.
NCT01960205 {published and unpublished data}
    1. NCT01960205. Effect of saxagliptin on pre‐diabetes mellitus and obesity. clinicaltrials.gov/ct2/show/NCT01960205 Date first received: 7 October 2013.
NCT02294084 {published data only}
    1. EudraCT: 2014‐003532‐39. The effect of the diabetes medication sitagliptin on brown fat and whole‐body metabolism in men with overweight and impaired glucose tolerance (or 'pre‐diabetes'). www.clinicaltrialsregister.eu/ctr‐search/trial/2014‐003532‐39/NL Date first registered: 15 October 2014.
    1. NCT02294084. Sitagliptin and brown adipose tissue (Sita01). clinicaltrials.gov/ct2/show/NCT02294084 Date first received: 17 November 2014.
Santilli 2015 {published data only}
    1. Santilli F, Guagnano M, Tartaro A, Simeone PG, Liani R, Tripaldi R, et al. Effects of liraglutide vs lifestyle changes on subcutaneous and visceral fat, liver steatosis, insulin sensitivity and beta cell function after comparable weight loss. Diabetologia 2015;58(1):S375.
    1. Santilli F, Guagnano MT, Tartaro A, Angelucci E, Simeone PG, Laronga G, et al. Liraglutide is more effective than lifestyle changes in modulating subcutaneous and visceral fat distribution, liver steatosis, insulin sensitivity and beta‐cell function after comparable weight loss. European Heart Journal 2015;36(0):473.
    1. Santilli F, Tartaro A, Guagnano MT, Simeone PG, Laronga G, Sborgia C, et al. Effects of liraglutide or lifestyle counseling on subcutaneous and visceral fat distribution, liver fat content, insulin sensitivity, and beta‐cell performance. Diabetes 2015;64:A287.
SCALE 2013 {published data only}
    1. Hollander P, Aronne L, Klein S, Niswender K, Jensen CB, Woo V, et al. Diet‐induced weight loss and subsequent addition of liraglutide 3.0 mg reduces impaired fasting glucose in overweight/obese adults in the SCALEtm maintenance 56‐week randomised trial. Journal of Diabetes 2013;5:124.
    1. Klein S, Aronne L, Hollander P, Niswender K, Bjorn Jensen C, Lindegaard M, et al. Effect of diet‐induced weight loss and subsequent addition of liraglutide 3.0 MG on impaired fasting glucose in overweight/obese adults in the SCALEtm maintenance 56‐week phase 3 randomised trial. Obesity Facts 2012;5:206.
    1. Klein S, Aronne LJ, Hollander P, Niswender K, Woo V, Hale PM, et al. Effect of liraglutide on cardiovascular (CV) risk factors in adults without diabetes after diet‐induced weight loss: the SCALE 56‐week randomized study. Obesity (Silver Spring, Md.) 2011; Vol. 19:S177.
    1. NCT00781937. Comparison of liraglutide versus placebo in weight loss maintenance in obese subjects: SCALE ‐ maintenance. clinicaltrials.gov/show/NCT00781937 Date first received: 28 October 2008.
    1. Wadden TA, Hollander P, Klein S, Niswender K, Woo V, Hale PM, et al. NN8022‐1923 Investigators. Weight maintenance and additional weight loss with liraglutide after low‐calorie‐diet‐induced weight loss: the SCALE maintenance randomized study. International Journal of Obesity 2013;37(11):1443‐51. [DOI: 10.1038/ijo.2013.120] - DOI - PubMed
SCALE‐SLEEP {published data only}
    1. Blackman A, Foster GD, Zammit G, Rosenberg R, Aronne L, Wadden T, et al. Effect of liraglutide 3.0 mg in individuals with obesity and moderate or severe obstructive sleep apnea: the SCALE sleep apnea randomized clinical trial. International Journal of Obesity 2016;40(8):1310‐9. [PUBMED: 27005405] - PMC - PubMed
    1. NCT01557166. Effect of liraglutide in obese subjects with moderate or severe obstructive sleep apnoea: SCALE™ ‐ sleep apnoea. clinicaltrials.gov/ct2/show/NCT01272232 Date first received: 6 January 2011.
    1. NN8022‐3970. Effect of liraglutide in obese subjects with moderate or severe obstructive sleep apnoea: SCALE™ ‐ sleep apnoea. novonordisk‐trials.com/Website/pdf/registry/nn80223970.pdf (accessed 30 September 2016).

References to ongoing studies

EudraCT 2013‐000418‐39 {published and unpublished data}
    1. Unpublished protocol. Provided by the investigators.
    1. EUCTR2013‐000418‐39‐AT. Early prevention of diabetes complications in people with hyperglycaemia in Europe ‐ e‐PREDICE. apps.who.int/trialsearch/Trial2.aspx?TrialID=EUCTR2013‐000418‐39‐AT (accessed 8 April 2016).
    1. EudraCT 2013‐000418‐39. Early prevention of diabetes complications in people with hyperglycaemia in Europe. www.clinicaltrialsregister.eu/ctr‐search/search?query=2013‐000418‐39 (accessed 17 March 2016).
    1. ePRECIDE. The project. www.epredice.eu/en/the‐project (accessed 17 March 2016).
Naidoo 2016 {published data only}
    1. Naidoo P, Wing J, Rambiritch V. Effect of sitagliptin and metformin on prediabetes progression to type 2 diabetes ‐ a randomized, double‐blind, double‐arm, multicenter clinical trial: protocol for the Sitagliptin and Metformin in PreDiabetes (SiMePreD) study. JMIR Research Protocols 2016;5(3):e145. [PUBMED: 27491324] - PMC - PubMed
NCT01234649 {published and unpublished data}
    1. NCT01234649. Combined liraglutide and metformin therapy in women with previous gestational diabetes mellitus (GDM). clinicaltrials.gov/ct2/show/NCT01234649 Date first received: 3 November 2010.
NCT01336322 {published and unpublished data}
    1. NCT01336322. Metformin and sitagliptin in women with previous gestational diabetes. clinicaltrials.gov/ct2/show/NCT01336322 Date first received: 13 April 2011.
NCT01548651 {published data only}
    1. NCT01548651. Effect of saxagliptin treatment on myocardial fat content, and monocyte inflammation. clinicaltrials.gov/ct2/show/NCT01548651 Date first received: 6 February 2012.
NCT01779362 {published data only}
    1. NCT01779362. RISE adult medication study (RISE Adult). clinicaltrials.gov/ct2/show/NCT01779362 Date first received: 28 January 2013.
    1. RISE Consortium. Restoring Insulin Secretion (RISE): design of studies of beta‐cell preservation in prediabetes and early type 2 diabetes across the life span. Diabetes Care 2014;37(3):780‐8. [PUBMED: 24194506] - PMC - PubMed
NCT01795248 {published and unpublished data}
    1. EudraCT 2012‐001371‐37. GDM‐TREAT. www.clinicaltrialsregister.eu/ctr‐search/trial/2012‐001371‐37/DK Date first registered: 9 July 2012.
    1. Foghsgaard S, Vedtofte L, Mathiesen ER, Svare JA, Gluud LL, Holst JJ, et al. The effect of a glucagon‐like peptide‐1 receptor agonist on glucose tolerance in women with previous gestational diabetes mellitus: protocol for an investigator‐initiated, randomised, placebo‐controlled, double‐blinded, parallel intervention trial. BMJ Open 2013;3(10):e003834. [PUBMED: 24176797] - PMC - PubMed
    1. NCT01795248. The impact of liraglutide on glucose tolerance and the risk of type 2 diabetes in women with previous pregnancy‐induced diabetes. clinicaltrials.gov/ct2/show/NCT01795248 Date first received: 18 February 2013.
NCT01856907 {published and unpublished data}
    1. NCT01856907. Sitagliptin + metformin compared to metformin monotherapy and placebo in women with a recent GDM. clinicaltrials.gov/ct2/show/NCT01856907 Date first received: 14 May 2013.
NCT02104739 {published and unpublished data}
    1. NCT02104739. Effects of antidiabetic medications on the postprandial state in prediabetes. clinicaltrials.gov/ct2/show/NCT02104739 Date first received: 1 April 2014.
NCT02140983 {published and unpublished data}
    1. NCT02140983. Effects of liraglutide on hippocampal structure and function in aging adults with prediabetes (LGT). clinicaltrials.gov/ct2/show/NCT02140983 Date first received: 27 January 2014.
NCT02488057 {published and unpublished data}
    1. NCT02488057. Improving beta cell function in Mexican American women with prediabetes. clinicaltrials.gov/ct2/show/NCT02488057 Date first received: 11 June 2015.
NCT02576288 {published data only}
    1. NCT02576288. Sitagliptin effects on arterial vasculature and inflammation in obesity (SAVORO). clinicaltrials.gov/ct2/show/NCT02576288 Date first received: 12 October 2015.
NCT02847403 {published data only}
    1. NCT02847403. Long‐acting exenatide and cognitive decline in dysglycemic patients (DRINN). clinicaltrials.gov/show/NCT02847403 Date first received: 21 July 2016.
NCT02969798 {published data only}
    1. NCT02969798. Pre‐diabetes in subject with impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). clinicaltrials.gov/show/NCT02969798 Date first received: 16 March 2016.
NCT03004612 {published data only}
    1. NCT03004612. Effect of linagliptin + metformin vs metformin alone in patients with prediabetes (PRELLIM). clinicaltrials.gov/show/NCT03004612 Date first received: 21 December 2016.
UMIN000008620 {published data only}
    1. UMIN000008620. The impact of DPP‐4 inhibitor on daily glucose profile and coronary plaque character in impaired glucose tolerance patients with coronary artery disease. upload.umin.ac.jp/cgi‐open‐bin/ctr/ctr.cgi?function=brows&action=bro... Date first received: 6 August 2012.

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