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

• Status: Completed
• Trial end date: 2019-01-13
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Steno Diabetes Center; Steno Diabetes Center Copenhagen
• Collaborators: AstraZeneca; Bayer; Rigshospitalet, Denmark; The Novo Nordic Foundation
• Treatments: Dapagliflozin; Metformin

Criteria

Inclusion Criteria:

• HbA1c: from ≥5.7% (39 mmol/mol) to ≤6.4% (47 mmol/mol)

• Age: from ≥30 to ≤70 years of age

• BMI ≥25 kg/m2

Exclusion Criteria:

• Uncontrolled medical issues including but not limited to cardiovascular pulmonary, rheumatologic, hematologic, oncologic, infectious, gastrointestinal or psychiatric disease; diabetes or other endocrine disease; immunosuppression;

• Current treatment with hormones which affect glucose metabolism;

• Current treatment with loop diuretics or thiazolidinediones;

• Current treatment with beta blockers or peroral steroids;

• Bariatric surgery within the past 2 years;

• Impaired renal function defined as an estimated GFR<60 ml/min/1.73m2;

• Neurogenic bladder disorders;

• Alcohol/drug abuse or in treatment with disulfiram (Antabus) at time of inclusion;

• Pregnant or lactating women;

• Fertile women not using birth control agents including oral contraceptives, gestagen injection, subdermal implants, hormonal vaginal ring, transdermal application, or intra-uterine devices;

• Allergic to one or more of the medications used in the study;

• Concomitant participation in other intervention study;

• Unable to understand the informed consent and the study procedures.