At a glance
ClinicalIndex Comparison Record- ✓Age 18–65 years
- ✓No known Type 2 Diabetes
- ✓Body mass index ≥27.5 kg/m²
- ✓Limited exercise: maximum 3 sessions/week of <30 minutes duration in the prior month
- ✕Clinically significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematologic, neurologic, or psychiatric disease that may interfere with study objectives or subject safety, or hospitalization for these conditions in past 2 years, or pharmacological treatment for these conditions
- ✕Habitual and/or recent tobacco use within 2 years
- ✕Prescription drugs (except birth control and short-course antibiotics) or herbal preparations in 2 weeks prior; weight-loss medications or metabolism-altering drugs in 4 weeks prior
- ✕Enrolled in another investigational study or took investigational drug within 30 days of screening
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Does Dapagliflozin Provide Additional Health Benefits To Dietary Counseling For Weight Loss?
In Brief
A Phase 2 clinical trial evaluating Dapagliflozin Tablet and Placebo Tablet for Weight Loss. Completed, enrolled 62 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.
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.