DECREASE: Dapagliflozin Plus Exenatide on Central REgulation of Appetite in diabeteS typE 2

Sponsor
Amsterdam UMC, location VUmc
Study ID
NCT03361098
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Dapagliflozin 10mg — DRUG
    Dapagliflozin 10mg oral tablet once daily
  • Exenatide — DRUG
    Exenatide 5 microgram b.i.d. week 1-4 Exenatide 10 microgram b.i.d. week 5-16
  • placebo exenatide — OTHER
    placebo b.i.d. exenatide
  • placebo dapagliflozin — OTHER
    placebo tablets dapagliflozin

Study Details

This is a 16 week, phase 4, randomized and placebo controlled trial, investigating the separate and combined effects of Sodium Glucose coTransporter 2 (SGLT2) inhibition with dapagliflozin and Glucagon Like peptide-1 (GLP-1) receptor agonism with exenatide on food intake, body weight and the neural activity in the central satiety and reward circuits in response to food-related stimuli by blood oxygen level-dependent (BOLD) fMRI in obese type 2 diabetes patients. The investigators hypothesize that treatment with SGLT2 inhibitors is associated with alterations in central reward and satiety circuits in response to food related stimuli, leading to increased appetite and food intake. In addition, the investigators hypothesize that adding a GLP-1 receptor agonist to the treatment with an SGLT2 inhibitor may increase weight loss and prevent the increased food intake during treatment with SGLT2 inhibitors due to effects on neuronal activity of central satiety and reward circuits in response to food-related stimuli in obese patients with T2DM.

Key Dates

Start date
Sep 18, 2017
Status verified
Jun 2021
Primary completion
Nov 25, 2019
Completion
Mar 25, 2020

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

Arms

  • Experimental: SGLT2 inhibitor + GLP-1 receptor agonist
    dapagliflozin 10 mg tablet /day and exenatide twice daily subcutaneous injection (week 1-4; 5 microgram, week 5 -16; 10 microgram)
  • Active Comparator: GLP-1 receptor agonist (exenatide) and placebo
    GLP-1 receptor agonist exenatide twice daily in combination with placebo dapagliflozin
  • Active Comparator: SGLT2 inhibitor (dapagliflozin) and placebo
    SGLT2 inhibitor dapagliflozin 10 mg tablet /day in combination with placebo GLP-1 receptor agonist exenatide twice daily
  • Placebo Comparator: double placebo
    placebo dapagliflozin and placebo exenatide twice daily

Primary Outcome Measure

Differences in neuronal activity in the central reward and satiety circuits in response to food-related stimuli by BOLD fMRI signal [ Time Frame: at baseline, after 10 days and after 16 weeks ]

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