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

Sponsor
Steno Diabetes Center Copenhagen
Study ID
NCT02695810
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
30 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

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

Study Details

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).

Key Dates

Start date
Feb 24, 2016
Status verified
Oct 2019
Primary completion
Sep 20, 2018
Completion
Jan 13, 2019

Study Design

Enrollment
120 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Dapagliflozin
    Dapagliflozin, 10 mg per day
  • Active Comparator: Metformin
    Metformin, 2 x 850 mg per day
  • Active Comparator: Exercise
    Exercise, interval training
  • No Intervention: Control
    No intervention

Primary Outcome Measure

Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring [ Time Frame: Change from baseline to 13 weeks and 26 weeks ]

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