CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Dapagliflozin +1 moredrug
Likely dose
Dapagliflozin 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02700334
NCT02700334Phase 4Completed

Effect of Dapagliflozin on Insulin Secretion and Insulin Sensitivity in Patients With Prediabetes

University of Guadalajara·interventional·Posted Mar 7, 2016·Updated Oct 28, 2020

In Brief

A Phase 4 clinical trial evaluating Dapagliflozin and Placebo for Prediabetes and 2 related conditions. Completed, enrolled 24 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesMexico
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 7, 2016
Enrollment StartOct 1, 2016
Primary CompletionJan 1, 2017
Study CompletionFeb 1, 2017
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 10.3 years ago

Interventions

Dapagliflozindrug

10 mg, one per day before breakfast during 12 weeks.

Placebodrug

one per day before breakfast during 12 weeks.