NCT03419624

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

A 28-week, Multi-center Randomized, Double-blind, Placebo-controlled Study to Evaluate the Potential of Dapagliflozin Plus Exenatide in Combination With High-dose Intensive Insulin Therapy Compared to Placebo in Obese Insulin-resistant Patients With Type 2 Diabetes Mellitus (Proof-of-concept Study)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Universitätsklinikum Hamburg-Eppendorf · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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%).

Detailed description

In this proof-of-concept study the potential of treatment with Dapagliflozin plus Exenatide added to high-dose intensive insulin therapy compared to Placebo added to high-dose intensive insulin with active insulin up-titration for change in HbA1c from baseline to week 28 shall be explored and generate initial data on the primary outcome. We hypothesize that SGLT-2 inhibition and GLP-1 receptor agonism may be a rational combination therapy that addresses a broad range of pathophysiological defects associated with T2DM in obesity and may reduce HbA1c levels in patients with severe insulin resistance. In a third treatment arm, patients will be treated with Exenatide monotherapy added to high-dose intensive Insulin therapy to study additive effects of Dapagliflozin and Exenatide.

Conditions

• Obesity
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Dapagliflozin 10mg	Dapagliflozin 10 mg tablet once daily
DRUG	Exenatide 2 mg [Bydureon]	Exenatide 2 mg injection once weekly
DRUG	Placebo Oral Tablet	Placebo oral tablet once daily
DRUG	Placebo injection	Placebo injection once weekly
DRUG	Insulin	daily Insulin injections
DRUG	Metformin, if taken before	If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.

Timeline

• Start date: 2018-02-19
• Primary completion: 2019-04-01
• Completion: 2019-08-05
• First posted: 2018-02-05
• Last updated: 2020-03-31

Locations

4 sites across 1 country: Germany