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

Sponsor
Maastricht University
Study ID
NCT03721874
Phase
PHASE4
Status
Completed

Conditions

  • Prediabetic State
  • Substrate Oxidation

Eligibility Criteria

Sex
ALL
Age
40 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Dapagliflozin 10mg — 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 — 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.

Study Details

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

Key Dates

Start date
Apr 30, 2019
Status verified
Aug 2021
Primary completion
Jun 29, 2021
Completion
Jun 29, 2021

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: 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.
  • Placebo Comparator: 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

Primary Outcome Measure

Change in nightly substrate oxidation measured as respiration quotient (RQ) during the sleeping period [ Time Frame: From screening to day 14 ]

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