Effect of dapagliflozin, metformin and physical activity on glucose variability, body composition and cardiovascular risk in pre-diabetes

The overall objective is to compare the short-term (3 months) effectiveness of three glucose-lowering interventions (physical activity, metformin, and dapagliflozin) on glucose variability, body composition, and cardiometabolic risk factors in overweight or obese individuals with pre-diabetes (HbA1c 6.0-6.4% / 42-47 mmol/mol). 

Design and method

The Pre-D Trial is an investigator-initiated, randomised, controlled, parallel, open-label, trial. The study aims to randomly assign 160 participants in a 1:1:1:1 ratio to receive one of four parallel group interventions for 13 weeks: 1) dapagliflozin (10 mg once daily); 2) metformin (850 mg twice daily); 3) physical activity (interval training, 5 days a week, 30 min per session); or 4) control (lifestyle advice). After the 13 weeks of intervention, a follow-up period of 13 weeks will follow to study the longer-term effects of the interventions. The primary endpoint is reduction in mean amplitude of glycaemic excursions from baseline to end-of treatment (measured by continuous glucose monitoring). Secondary endpoints include changes in various measures of glucose metabolism, body weight, cardiometabolic risk factors, and objectively measured physical activity. 

Target group
Eligible participants are overweight or obese adults aged 30-70 years who meet the eligibility criteria for pre-diabetes defined by HbA1c 42-47 mmol/mol (6.0-6.5%).

Expected ending and outcome
The study is expected to run from February 2016 to December 2017. 

Steno study group
Kristine Færch (sponsor)
Marit Eika Jørgensen (principal investigator)
Hanan Amadid (MD, PhD student)
Lea Bruhn Nielsen (MSc, PhD student)
Frederik Persson (consultant)

External collaborators
Mathias Ried-Larsen and Kristian Karstoft, Rigshospitalet

Sidst opdateret 11-07-2016

Responsible

Kristine Færch
Team leader

E-mail krif@steno.dk
Phone +45 30 79 14 61