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

Steno Diabetes Centers

Status and phase: Completed; Phase 2

Conditions: Prediabetic State; Obesity

Treatments: Drug: Dapagliflozin; Drug: Metformin; Behavioral: Exercise

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02695810

2015-001552-30

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 4 patient groups

Dapagliflozin

Experimental group

Description:

Dapagliflozin, 10 mg per day

Treatment:

Drug: Dapagliflozin

Metformin

Active Comparator group

Description:

Metformin, 2 x 850 mg per day

Treatment:

Drug: Metformin

Exercise

Active Comparator group

Description:

Exercise, interval training

Treatment:

Behavioral: Exercise

Control

No Intervention group

Description:

No intervention