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Completed

NCT Number: NCT02695810

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

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).

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Key information

Conditions

Prediabetic State Body Weight Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Steno Diabetes Center A/S

Gentofte Municipality, 2820, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dapagliflozin

Drug

10 mg per day as monotherapy for 13 weeks

Other names: Forxiga, AstraZeneca

metformin

Drug

2 x 850 mg per day as monotherapy for 13 weeks

Other names: Aurobindo, Orion Pharma

Exercise

Behavioral

Interval training, 5 times per week, 30 min per session

Primary outcomes

  1. Mean amplitude of glycaemic excursions (MAGE) as assessed by continuous glucose monitoring

    Time frame: Change from baseline to 13 weeks and 26 weeks

Secondary outcomes

  1. Intra-day glycaemic variability as assessed by continuous overall net glycaemic action (CONGA)

    Time frame: Change from baseline to 13 weeks and 26 weeks

  2. Daily time spent above different glucose concentrations ( e.g. >6.1 mmol/L, >7.0 mmol/L, >7.8 mmol/L, and >11.1 mmol/L)

    Time frame: Change from baseline to 13 weeks and 26 weeks

  3. HbA1c

    Time frame: Change from baseline to 13 weeks and 26 weeks

  4. Glucose concentrations during OGTT

    Time frame: Change from baseline to 13 weeks and 26 weeks

  5. Insulin secretion as assessed by the insulinogenic index

    Time frame: Change from baseline to 13 weeks and 26 weeks

  6. Insulin sensitivity as assessed by the insulin sensitivity index

    Time frame: Change from baseline to 13 weeks and 26 weeks

  7. Body weight (kg)

    Time frame: Change from baseline to 13 weeks and 26 weeks

  8. Body fat (%) as assessed by DEXA scan

    Time frame: Change from baseline to 13 weeks and 26 weeks

  9. Cardiorespiratory fitness as assessed by maximal oxygen uptake (VO2 max)

    Time frame: Change from baseline to 13 weeks and 26 weeks

  10. Respiratory exchange ratio (RER) as assessed by indirect calorimetry

    Time frame: Change from baseline to 13 weeks and 26 weeks

  11. Basal metabolic rate (BMR) as assessed by indirect calorimetry

    Time frame: Change from baseline to 13 weeks and 26 weeks

  12. Time spent sedentary and in moderate-to-vigorous physical activity intensity as assessed by accelerometer

    Time frame: Change from baseline to 13 weeks and 26 weeks

  13. Systolic and diastolic blood pressure

    Time frame: Change from baseline to 13 weeks and 26 weeks

  14. Plasma lipids

    Time frame: Change from baseline to 13 weeks and 26 weeks

  15. Number of self-reported adverse events and side effects

    Time frame: Change from baseline to 13 weeks and 26 weeks

  16. Self-rated health and quality of life as assessed by questionnaire

    Time frame: Change from baseline to 13 weeks and 26 weeks

  17. Sleep habits as assessed by questionnaire

    Time frame: Change from baseline to 13 weeks and 26 weeks

  18. Dietary intake as assessed by a food diary

    Time frame: Change from baseline to 13 weeks and 26 weeks

  19. Adherence to the different interventions as assessed by number of tablets returned or number of training passes completed

    Time frame: Change from baseline to 13 weeks and 26 weeks

  20. Responsiveness to interventions in individuals with different glucose tolerance status (impaired fasting glycaemia vs. impaired glucose tolerance)

    Time frame: Change from baseline to 13 weeks and 26 weeks

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • AstraZeneca
  • Bayer
  • Rigshospitalet, Denmark
  • The Novo Nordic Foundation

Registry information

Official study title

Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk in Pre-diabetes

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Mar 1, 2016
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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