Exploratory Study to Investigate the Effect of Dapagliflozin and Exenatide Combined on Body Weight
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
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.