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

S

Steno Diabetes Centers

Status and phase

Completed
Phase 2

Conditions

Prediabetic State
Obesity

Treatments

Drug: Dapagliflozin
Behavioral: Exercise
Drug: Metformin

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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