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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-24

Study Completion Date

2019-01-13

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prediabetic State Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Dapagliflozin

Dapagliflozin, 10 mg per day

Group Type EXPERIMENTAL

Dapagliflozin

Intervention Type DRUG

10 mg per day as monotherapy for 13 weeks

Metformin

Metformin, 2 x 850 mg per day

Group Type ACTIVE_COMPARATOR

Metformin

Intervention Type DRUG

2 x 850 mg per day as monotherapy for 13 weeks

Exercise

Exercise, interval training

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type BEHAVIORAL

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

Control

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Dapagliflozin

10 mg per day as monotherapy for 13 weeks

Intervention Type DRUG

Metformin

2 x 850 mg per day as monotherapy for 13 weeks

Intervention Type DRUG

Exercise

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Forxiga, AstraZeneca Aurobindo, Orion Pharma

Eligibility Criteria

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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.

Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes