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

Sponsor
Universitätsklinikum Hamburg-Eppendorf
Study ID
NCT03419624
Phase
PHASE3
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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%).

Key Dates

Start date
Feb 19, 2018
Status verified
Mar 2020
Primary completion
Apr 1, 2019
Completion
Aug 5, 2019

Study Design

Enrollment
13 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dapagliflozin plus Exenatide
    Dapagliflozin (10mg orally once daily) plus Exenatide (2mg subcutaneous once-weekly injection) as add-on to high-dose intensive insulin therapy
  • Placebo Comparator: Placebo plus Placebo
    Placebo (film-coated tablet once daily) plus Placebo (subcutaneous once-weekly injection) as add-on to high-dose intensive insulin therapy
  • Active Comparator: Placebo plus Exenatide
    Placebo (film-coated tablet once daily) plus Exenatide (2mg subcutaneous once- weekly injection) as add-on to high dose intensive insulin therapy

Primary Outcome Measure

Change in HbA1c from baseline (week 0) to week 28 [ Time Frame: 28 weeks ]

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