The Potential of Dapagliflozin Plus Exenatide in Obese Insulin-resistant Patients

NCT03419624 · Terminated

Last updated 2026-05-28

This clinical trial tests whether combining the medications dapagliflozin and exenatide can help lower blood sugar levels in adults with obesity and type 2 diabetes over a 28-week period.

Status Terminated Stopped early and will not restart.

Phase Phase 3 Confirms effectiveness in a large group before approval.

Type Interventional (clinical trial)

Design Randomized, double-blind treatment study

Participants 13 people

Who can join Ages 18–75 · all sexes

Timeline Started 2018-02 · est. completion 2019-08

Where 4 sites · Germany

What this study is testing ClinicalTrials.gov NCT03419624 ↗

Description as written by the study sponsor.

This is a 28-week, multi-center, randomized, double-blind, placebo-controlled trial to study a potential synergistic effect of Dapagliflozin plus Exenatide once-weekly in combination with high-dose intensive insulin therapy compared to Placebo in obese insulin-resistant patients with Type 2 Diabetes mellitus (T2DM) and inadequate glycemic control (HbA1c≥8.0% and ≤ 11.0%).

Treatments tested

Dapagliflozin 10mg Drug

Dapagliflozin 10 mg tablet once daily
Exenatide 2 mg [Bydureon] Drug

Exenatide 2 mg injection once weekly
Placebo Oral Tablet Drug

Placebo oral tablet once daily
Placebo injection Drug

Placebo injection once weekly
Insulin Drug

daily Insulin injections
Metformin, if taken before Drug

If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.

Main thing measured	Change in HbA1c from baseline (week 0) to week 28
Sponsor	Universitätsklinikum Hamburg-Eppendorf
Conditions studied	Obesity, Diabetes Mellitus, Type 2
GLP-1 drugs	exenatide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT03419624 ↗