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. 2016 Apr 21;4(4):CD012106.
doi: 10.1002/14651858.CD012106.pub2.

Sodium-glucose cotransporter (SGLT) 2 inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus

Bianca Hemmingsen  1 , Jesper Krogh, Maria-Inti Metzendorf, Bernd Richter
Affiliations

Sodium-glucose cotransporter (SGLT) 2 inhibitors for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus

Bianca Hemmingsen et al. Cochrane Database Syst Rev. .

Abstract

Background: Sodium-glucose cotransporter (SGLT) 2 inhibitors were recently approved as glucose-lowering interventions in people with type 2 diabetes mellitus (T2DM). Potential beneficial or harmful effects of SGLT 2 inhibitors in people at risk for the development of T2DM are unknown.

Objectives: To assess the effects of SGLT 2 inhibitors focusing on the prevention or delay of T2DM and its associated complications in people with impaired glucose tolerance, impaired fasting blood glucose or moderately elevated glycosylated haemoglobin A1c (HbA1c) or any combination of these.

Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, PubMed, EMBASE, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) and reference lists of systematic reviews, articles and health technology assessment reports. We asked investigators of ongoing for information about additional trials. The date of the last search of all databases was January 2016.

Selection criteria: Randomised controlled trials (RCTs) of any duration comparing SGLT 2 inhibitors with any 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, assessed quality and extracted data independently. We resolved discrepancies by consensus or the involvement of a third author.

Main results: We could not include any RCT in this systematic review. One trial was published in two abstracts, but did not provide separate information of the participants with impaired glucose tolerance, impaired fasting glucose or both. We identified two ongoing trials, both evaluating the effects of dapagliflozin (and metformin) in people at risk for the development of type 2 diabetes and a follow-up of 24 to 26 weeks. Both trials will mainly report on surrogate outcome measures with some data on adverse effects and health-related quality of life.

Authors' conclusions: Due to lack of data it is not possible to conclude whether SGLT 2 inhibitors prevent or delay the diagnosis of T2DM and its associated complications.

PubMed Disclaimer

Conflict of interest statement

BH: this review is part of a series of reviews on interventions for prevention or delay of type 2 diabetes mellitus and its associated complications in persons at increased risk for the development of type 2 diabetes mellitus which is funded by the WHO.

JK: none known.

MIM: none known.

BR: none known.

Figures

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Study flow diagram.
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References

References to studies excluded from this review

NCT01248364 {published data only}
    1. A Study to Determine Acute (After First Dose) and Chronic (After 28 Days) Effects of Empagliflozin (BI 10773) on Pre and Postprandial Glucose Homeostasis in Patients With Impaired Glucose Tolerance and Type 2 Diabetes Mellitus and Healthy Subjects. https://clinicaltrials.gov/ct2/show/study/NCT01248364 (accessed 8 March 2016).

References to ongoing studies

EudraCT 2015‐001552‐30 {published and unpublished data}
    1. Effect of dapagliflozin, metformin and physical activity on glucose variability, body composition and cardiovascular risk in pre‐diabetes (The PRE‐D Trial) ‐ a randomised, parallel, open‐label, intervention study. https://www.clinicaltrialsregister.eu/ctr‐search/trial/2015‐001552‐30/DK/ (accessed 8 March 2016).
NCT02338193 {published data only}
    1. Dapagliflozin and metformin, alone and in combination, in overweight/obese prior GDM women (DAPA‐GDM). https://clinicaltrials.gov/ct2/show/NCT02338193 (accessed 5 March 2016).

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