Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes
Summary
Prediabetes is a term that refers to alterations in glucose homeostasis, including impaired fasting glucose (IFG), impaired glucose tolerance (IGT) or both, involving a higher risk of progression type 2 diabetes mellitus (T2DM). Dapagliflozin is a selective and reversible inhibitor of sodium-glucose type 2 (SGLT-2) co-transporter, which reduces renal glucose reabsorption and promotes the glucose excretion through urine, so that the blood glucose is improved in patients with T2DM. Although this mechanism is independent of insulin, there are evidence of improved secretion and insulin sensitivity, so it is interesting to assess these effects in patients with prediabetes, as potential therapy for treating such disorders and prevent progression to T2DM. The aim of this study is to evaluate the effect of Dapagliflozin on insulin secretion and insulin sensitivity in patients with prediabetes. The investigators hypothesis is that the administration of dapagliflozin improve insulin secretion and insulin sensitivity in patients with prediabetes.
Timeline
- Start
- 2016-10
- Primary completion
- 2017-01
- Completion
- 2017-02
Outcome
Mixed primary results
registry MEAN Dapagliflozin: 5.1 (Standard Deviation 0.3) mmol/L MEAN Placebo: 5.9 (Standard Deviation 0.5) mmol/L NCT02700334 ↗
registry analysis (other test); Dapagliflozin vs Placebo; p = 0.005; Wilcoxon (Mann-Whitney) NCT02700334 ↗
registry MEAN Dapagliflozin: 8.4 (Standard Deviation 1.5) mmol/L MEAN Placebo: 8.7 (Standard Deviation 2.7) mmol/L NCT02700334 ↗
registry analysis (other test); Dapagliflozin vs Placebo; p = 0.093; Wilcoxon (Mann-Whitney) NCT02700334 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dapagliflozin | Small molecule | 10 mg | Oral |