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

What Was Tested

In this phase 2 trial, researchers set out to test Exenatide.

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.

It had two arms (groups): Dapagliflozin and exenatide (experimental) and Placebo (placebo comparator).

Placebo film-coated tablet once daily and placebo once weekly injection combined treatment for 24 weeks.

The registry classes the interventions as drug.

Who Took Part

50 actual participants took part.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of signed informed consent prior to any study specific procedures. Female and/or male aged 18 to 70 years with body mass index (BMI) (measured as body weight (kg)/(height (m))2) 30 to 45 kg/m2. Female subjects must meet all of the following criteria:. Negative pregnancy test result (human chorionic gonadotropin, beta subunit \[beta hCG\]) at Visit 1 (Enrolment) (not applicable to hysterectomized females). Placement of an intrauterine device.

The full record lists 20 inclusion and 18 exclusion criteria; among the exclusions: involvement in the planning and/or conduct of the study; previous enrolment in the present study; participation in another clinical study with an investigational product during the last 3 months prior to visit 1.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

The participants were allocated by chance, so the Exenatide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

As a double-blind Exenatide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider and investigator.

It started in 2014-12 with completion listed for 2016-03.

It ran at 1 site in Sweden.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Body weight (kg) (time frame: From randomization to 24 weeks).

It also tracked 1 secondary outcome, for example Body weight (%).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Exenatide in 50 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Exenatide compound page, all human trials.