NCT03180489

Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 62 (actual)
• Sponsor: Christopher Bell · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Dapagliflozin is a medicine to treat diabetes. Its mechanism of action is via sodium-glucose co-transporter 2 (SGLT2) inhibition. In adults with diabetes, use of sodium-glucose co-transporter 2 inhibitors is associated with moderate weight (fat) loss, in addition to other health benefits, including decreased blood pressure, decreased inflammation, and decreased oxidative stress. It is unclear as to whether these health benefits are due to SGLT2 inhibition per se, or as a secondary effect of weight loss. We wish to compare the health benefits of dietary counseling for weight loss with and without concomitant use of an SGLT2 inhibitor.

Detailed description

This is a randomized, prospective, placebo-controlled, double blind, repeated measures study. 50 overweight/obese adults (body mas index \> 27.5 kg/m2) will be recruited for participation and randomly assigned to one of two 12 week treatments: (1) daily oral administration of Dapagliflozin with dietary counseling to promote weight loss; or, (2) daily oral administration of a placebo with dietary counseling to promote weight loss.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DRUG	Dapagliflozin Tablet	Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
DRUG	Placebo Tablet	Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.

Timeline

• Start date: 2017-05-03
• Primary completion: 2018-12-21
• Completion: 2018-12-21
• First posted: 2017-06-08
• Last updated: 2020-02-11
• Results posted: 2020-02-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study