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

NCT02695810 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2019-10-07

No results posted yet for this study

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 mmol/mol).

Conditions

Interventions

DRUG

Dapagliflozin

10 mg per day as monotherapy for 13 weeks

DRUG

Metformin

2 x 850 mg per day as monotherapy for 13 weeks

BEHAVIORAL

Exercise

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

Sponsors & Collaborators

  • The Novo Nordic Foundation

    collaborator OTHER

  • Rigshospitalet, Denmark

    collaborator OTHER

  • AstraZeneca

    collaborator INDUSTRY

  • Bayer

    collaborator INDUSTRY

  • Steno Diabetes Center Copenhagen

    lead OTHER

Principal Investigators

  • Marit E Jørgensen, PhD · Steno Diabetes Center Copenhagen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-24
Primary Completion
2018-09-20
Completion
2019-01-13

Countries

  • Denmark

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02695810 on ClinicalTrials.gov