Effects of 2 Weeks Treatment With Dapagliflozin in Subjects With an Impaired Glucose Homeostasis on Nocturnal Substrate Oxidation

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

PHASE4

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-30

Study Completion Date

2021-06-29

Brief Summary

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The purpose of this study is to investigate the effect of 2 weeks dapagliflozin treatment in individuals with a disrupted glucose homeostasis on the switch between carbohydrate and lipid oxidation during the night

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Detailed Description

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To investigate if dapagliflozin improves nocturnal substrate oxidation expressed as respiration quotient (RQ) during the sleeping period in comparison with placebo after 2-weeks double blind treatment in subjects with a disrupted glucose homeostasis.

Conditions

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Prediabetic State Substrate Oxidation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Double-Blind, Randomized, Phase IV, Mechanistic, Placebo-Controlled, Cross-Over, Single-Center Study

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Dapagliflozin 10 mg

Patients will receive dapagliflozin 10 mg in tablet for a maximum of 14 days based on randomization sequence in Period 1.

Patients that received 10 mg dapagliflozin in the first treatment period will receive matching placebo in the second treatment period for a maximum of 14 days.

Group Type ACTIVE_COMPARATOR

Dapagliflozin 10mg

Intervention Type DRUG

The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.

The subject may be administered dapagliflozin 10 mg during Period 1 or Period 2.

Placebo matching to dapagliflozin 10 mg

Patients will receive matching placebo in tablet for a maximum of 14 days based on randomization sequence.

Patients who received placebo in the first treatment will receive 10 mg dapagliflozin in the second treatment period, for a maximum of 14 days

Group Type PLACEBO_COMPARATOR

Placebo matching to Dapagliflozin 10 mg

Intervention Type DRUG

The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.

The subject may be administered placebo during Period 1 or Period 2.

Interventions

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Dapagliflozin 10mg

The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.

The subject may be administered dapagliflozin 10 mg during Period 1 or Period 2.

Intervention Type DRUG

Placebo matching to Dapagliflozin 10 mg

The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.

The subject may be administered placebo during Period 1 or Period 2.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Provision of signed and dated informed consent prior to any study specific procedures.
2. Males aged ≥ 40 and ≤ 75 years and post-menopausal women (defined as at least 1 year post cessation of menses) aged ≥ 50 and ≤ 75 years
3. Body mass index (BMI) ≥ 27 and ≤ 38 kg/m2.
4. Sedentary lifestyle (not more than 3 hours of programmed exercise per week).
5. Stable dietary habits.
6. Impaired glucose homeostasis based on one or a combination of the following criteria:

* Impaired Glucose Tolerance (IGT): plasma glucose values ≥ 7.8 mmol/l and ≤ 11.1 mmol/l 120 minutes after consumption of the glucose drink during the 2h, 3-point OGTT.
* Impaired Fasting Glucose (IFG): fasting plasma glucose ≥ 6.1 mmol/l and ≤ 6.9 mmol/l.
* Insulin Resistance: glucose clearance rate ≤ 360 ml/kg/min, as calculated by Oral Glucose Insulin Sensitivity 120 (OGIS120) model based on the 2h, 3-point OGTT.
* HbA1c ≥ 5.7% and ≤ 6.4%.

Exclusion Criteria

1. Clinical diagnosis of Type 1 or 2 Diabetes Mellitus.
2. Active cardiovascular disease: participants who experienced a heart attack in the last year, or participants who are currently under regular control of a physician for a heart condition.
3. Weight gain or loss \> 5 kg in the last 3 months, ongoing weight-loss diet (hypocaloric diet) or use of weight loss agents.
4. Regular smoking and other regular nicotine use.
5. Anaemia.
6. Uncontrolled hypertension.
7. Clinically significant out of range values of serum levels of either alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP) in the Investigator's opinion.
8. Unstable or rapidly progressing renal disease or estimated Glomerular Filtration Rate (eGFR) \<60 mL/min (Cockcroft-Gault formula).
9. Use of anti-coagulant treatment and other concomitant medication will be evaluated on a case to case basis with a general physician.
10. Use of medication such as oral glucocorticoids, anti-estrogens or other medications that are known to markedly influence insulin sensitivity.
11. Use of loop diuretics.
12. Intake of dietary supplements except multi-vitamins and minerals.
13. Alcohol consumption of \> 14 drinks per week for women and \> 21 drinks per week for men (1 drink = 35 cl beer, 14 cl wine or 4 cl hard liquor).
14. Known hypersensitivity to dapagliflozin or any of the excipients of the product.
15. For women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.
16. Participation in another biomedical study within 1 month before the screening visit.
17. Any contraindication for MRI scanning.
18. Participants who do not want to be informed about unexpected medical findings, or do not wish that their physician be informed about coincidental findings, cannot participate in the study.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes