CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Exenatide/Exenatide extended release +2 moredrug
Likely dose
Exenatide/Exenatide extended release 5µgfrom 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/NCT02962492
NCT02962492N/ACompleted

An Investigation Into the Effect of Dapagliflozin on Ketogenesis in Type 1 Diabetes

University at Buffalo·interventional·Posted Nov 11, 2016·Updated Feb 29, 2024

In Brief

A clinical study evaluating Exenatide/Exenatide extended release, Dapagliflozin, and 1 other intervention for Evaluate Ketogenic Stress. Completed, enrolled 70 participants across 1 site.

Detailed Summary

The study investigations include evaluation of the acute effects of a single dose of dapagliflozin (10mg), exenatide (5µg), a combination of exenatide and dapagliflozin or placebo under insulinopenic condition and the long term effect under basal conditions before and after 12 weeks treatment with dapagliflozin, Exenatide extended release, a combination of Exenatide extended release and dapagliflozin or placebo on ketogenesis, glucagon and lipolysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAstraZeneca

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 11, 2016
Enrollment StartNov 1, 2016
Primary CompletionFeb 1, 2021
Study CompletionOct 24, 2021
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 9.6 years ago

Interventions

Exenatide/Exenatide extended releasedrug

Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks

Dapagliflozindrug

Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks

Placebodrug

Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks