NCT02695810

The PRE-D Trial: Effect of Dapagliflozin, Metformin and Physical Activity in Pre-diabetes

Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Steno Diabetes Center Copenhagen · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (dapagliflozin, metformin and physical activity) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 5.7-6.4% / 39-47 mmol/mol).

Detailed description

Different medical therapies and lifestyle modification for the prevention of type 2 diabetes have yet to be compared head-to-head in individuals with pre-diabetes. This research project will compare different glucose-lowering interventions in overweight and obese individuals with HbA1c levels in the pre-diabetic range.

Conditions

• Prediabetic State
• Obesity

Interventions

Type	Name	Description
DRUG	Dapagliflozin	10 mg per day as monotherapy for 13 weeks
DRUG	Metformin	2 x 850 mg per day as monotherapy for 13 weeks
BEHAVIORAL	Exercise	Interval training, 5 times per week, 30 min per session

Timeline

• Start date: 2016-02-24
• Primary completion: 2018-09-20
• Completion: 2019-01-13
• First posted: 2016-03-01
• Last updated: 2019-10-07

Locations

1 site across 1 country: Denmark