Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight

Sponsor
Uppsala University
Study ID
NCT02313220
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin — DRUG
    Oral use
  • Exenatide — DRUG
    Powder and solvent for suspension for injection, prolonged release suspension. Subcutaneous use.
  • Placebo — DRUG
    Oral and Subcutaneous use.

Study Details

Obesity is a medical condition which increases the risk of other diseases, such as type 2 diabetes and cardiovascular disease. Obesity-related risk factors for the development of other metabolic diseases include unstable glucose levels and high blood pressure. Dapagliflozin and exenatide are both approved worldwide for treatment of patients with Type 2 Diabetes. Dapagliflozin works by lowering glucose levels by inhibiting the renal reabsorption of glucose and thereby promoting its urinary excretion and energy loss and thereby reduction in body fat. Exenatide exhibits many of the same glucose-lowering actions of that of a naturally occurring hormone and leads to weight loss mainly via reduced energy intake, most likely via a central effect on appetite regulation. The purpose of this exploratory study is to investigate if a combination treatment with dapagliflozin and exenatide have a synergistic effect on weight loss in non-diabetic obese subjects. Subjects will be treated for 24 weeks with either active combination treatment or placebo (non-active treatment). Neither study personnel nor subjects will know what treatment is given. All subjects completing the 24-week double-blind study and who are willing and eligible will be offered to enter a 28-week open-label extension study. All subjects entering the extension study will receive unblinded active study treatment for an additional 28 weeks. Thus the total treatment period for subjects entering the extension study will be 52 weeks.

Key Dates

Start date
Dec 31, 2014
Status verified
Nov 2016
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

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

Arms

  • Experimental: Dapagliflozin and exenatide
    Dapagliflozin 10 mg film-coated tablet once daily and exenatide 2 mg once weekly injection combined treatment for 24 weeks
  • Placebo Comparator: Placebo
    Placebo film-coated tablet once daily and placebo once weekly injection combined treatment for 24 weeks

Primary Outcome Measure

Body weight (kg) [ Time Frame: From randomization to 24 weeks ]

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