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

NCT03419624 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2020-03-31

No results posted yet for this study

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%).

Conditions

  • Obesity
  • Diabetes Mellitus, Type 2

Interventions

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.

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Jens Aberle, MD · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-19
Primary Completion
2019-04-01
Completion
2019-08-05

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03419624 on ClinicalTrials.gov