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

NCT02962492 · Completed

Last updated 2026-05-28

This clinical trial tests whether the medication dapagliflozin affects the production of ketones in people with type 1 diabetes.

Status Completed The study has finished.

Phase Not applicable Not a phased drug trial (e.g. a device or behavioral study).

Type Interventional (clinical trial)

Design Randomized, triple-blind basic-science study

Participants 70 people

Who can join Ages 18–65 · all sexes

Timeline Started 2016-11 · est. completion 2021-10

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT02962492 ↗

Description as written by the study sponsor.

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.

Treatments tested

Exenatide/Exenatide extended release also known as Bydureon Drug

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
Dapagliflozin also known as Farxiga Drug

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
Placebo also known as Placebo for both active drugs Drug

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

Main thing measured	Change in Beta-hydroxybutyrate Levels in Blood
Sponsor	University at Buffalo
Conditions studied	Evaluate Ketogenic Stress
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT02962492 ↗