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Prediabetic StatePhase 2NCT02695810

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

A Phase 2 study testing Dapagliflozin, Metformin and Exercise in people with Prediabetic State and Obesity, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 30 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Prediabetic State, Obesity
What is being tested?
Dapagliflozin, Metformin and Exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteDenmark
Study dates
24 Feb 2016to 13 Jan 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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;
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  • 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 locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center A/S

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

Official title: Effect of Dapagliflozin, Metformin and Physical Activity on Glucose Variability, Body Composition and Cardiovascular Risk 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).

Read the detailed 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.

Being tested
Dapagliflozin, Metformin, Exercise
Medical subject headings
Prediabetic State, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DapagliflozinDrug

    Also called Forxiga, AstraZeneca

    10 mg per day as monotherapy for 13 weeks

  • MetforminDrug

    Also called Aurobindo, Orion Pharma

    2 x 850 mg per day as monotherapy for 13 weeks

  • ExerciseBehavioural

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

Study groups in NCT02695810
Study groupRoleWhat they receive
DapagliflozinExperimentalDapagliflozin, 10 mg per day
Receives: Drug: Dapagliflozin
MetforminActive comparatorMetformin, 2 x 850 mg per day
Receives: Drug: Metformin
ExerciseActive comparatorExercise, interval training
Receives: Behavioral: Exercise
ControlNo interventionNo intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Change from baseline to 13 weeks and 26 weeks

Secondary outcomes (20)

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

    Measured: 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)

    Measured: Change from baseline to 13 weeks and 26 weeks

  3. HbA1c

    Measured: Change from baseline to 13 weeks and 26 weeks

  4. Glucose concentrations during OGTT

    Measured: Change from baseline to 13 weeks and 26 weeks

  5. Insulin secretion as assessed by the insulinogenic index

    Measured: Change from baseline to 13 weeks and 26 weeks

  6. Insulin sensitivity as assessed by the insulin sensitivity index

    Measured: Change from baseline to 13 weeks and 26 weeks

  7. Body weight (kg)

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: 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

    Measured: Change from baseline to 13 weeks and 26 weeks

  13. Systolic and diastolic blood pressure

    Measured: Change from baseline to 13 weeks and 26 weeks

  14. Plasma lipids

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: Change from baseline to 13 weeks and 26 weeks

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

    Measured: Change from baseline to 13 weeks and 26 weeks

  17. Sleep habits as assessed by questionnaire

    Measured: Change from baseline to 13 weeks and 26 weeks

  18. Dietary intake as assessed by a food diary

    Measured: 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

    Measured: 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)

    Measured: Change from baseline to 13 weeks and 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2016 (estimated)
  2. Study start24 Feb 2016
  3. Primary completion20 Sep 2018
  4. Study completion13 Jan 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02695810
Sponsor's protocol ID
2015-001552-30
Other IDs
2015
Status last verified
Oct 2019
First submitted
9 Feb 2016
Last updated
7 Oct 2019
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Perreault L, Faerch K. Approaching pre-diabetes. J Diabetes Complications. 2014 Mar-Apr;28(2):226-33. doi: 10.1016/j.jdiacomp.2013.10.008. Epub 2013 Oct 28.

    PubMed 24342268

  • Faerch K, Hulman A, Solomon TP. Heterogeneity of Pre-diabetes and Type 2 Diabetes: Implications for Prediction, Prevention and Treatment Responsiveness. Curr Diabetes Rev. 2016;12(1):30-41. doi: 10.2174/1573399811666150416122903.

    PubMed 25877695

  • Faerch K, Vistisen D, Johansen NB, Jorgensen ME. Cardiovascular risk stratification and management in pre-diabetes. Curr Diab Rep. 2014 Jun;14(6):493. doi: 10.1007/s11892-014-0493-1.

    PubMed 24743942

  • Hulman A, Foreman YD, Brouwers MCGJ, Kroon AA, Reesink KD, Dagnelie PC, van der Kallen CJH, Greevenbroek MMJV, Faerch K, Vistisen D, Jorgensen ME, Stehouwer CDA, Witte DR. Towards precision medicine in diabetes? A critical review of glucotypes. PLoS Biol. 2021 Mar 11;19(3):e3000890. doi: 10.1371/journal.pbio.3000890. eCollection 2021 Mar.

    PubMed 33705389

  • Faerch K, Blond MB, Bruhn L, Amadid H, Vistisen D, Clemmensen KKB, Vaino CTR, Pedersen C, Tvermosegaard M, Dejgaard TF, Karstoft K, Ried-Larsen M, Persson F, Jorgensen ME. The effects of dapagliflozin, metformin or exercise on glycaemic variability in overweight or obese individuals with prediabetes (the PRE-D Trial): a multi-arm, randomised, controlled trial. Diabetologia. 2021 Jan;64(1):42-55. doi: 10.1007/s00125-020-05306-1. Epub 2020 Oct 16.

    PubMed 33064182

  • Faerch K, Amadid H, Nielsen LB, Ried-Larsen M, Karstoft K, Persson F, Jorgensen ME. Protocol for a randomised controlled trial of the effect of dapagliflozin, metformin and exercise on glycaemic variability, body composition and cardiovascular risk in prediabetes (the PRE-D Trial). BMJ Open. 2017 Jun 6;7(5):e013802. doi: 10.1136/bmjopen-2016-013802.

    PubMed 28592573

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dapagliflozin, Metformin and Exercise in people with Prediabetic State and Obesity, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02695810, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2019.

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