Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose

Sponsor
Oslo University Hospital
Study ID
NCT04662866
Phase
PHASE2
Status
Unknown

Conditions

  • Glucose Metabolism Disorders
  • Impaired Glucose Tolerance
  • Insulin Sensitivity

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This study will test the effect of four common oral anti-diabetic agents on hepatic insulin sensitivity in South Asian women with impaired glucose tolerance or impaired fasting glucose. In a 12-week, double-blind, randomized controlled intervention trial, the following drugs will be tested head-to-head: Metformin, Pioglitazone, Empagliflozin and Linagliptin. Additional, exploratory outcomes include whole body insulin sensitivity, insulin secretion and other markers of glucose and lipid metabolism, measured by the euglycemic clamp with stable isotope tracer dilution, indirect calorimetry and CT-measurements of abdominal adipose tissue compartment volumes and hepatic and pancreatic volume and attenuation. The study is part of the DIASA - DIAbetes in South Asians - Research Programme, which aims to find ways to improve both prevention and treatment of type 2 diabetes in people of South Asian ethnicity.

Key Dates

Start date
Feb 10, 2021
Status verified
Apr 2021
Primary completion
Dec 31, 2022
Completion
Oct 31, 2023

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Metformin
    Metformin 500 mg x 1, morning, for 2 weeks, then Metformin 500 mg x 2, morning and evening for 10 weeks.
  • Active Comparator: Empagliflozin
    Empagliflozin 10 mg x 1, morning, for 2 weeks, then Empagliflozin 10 mg morning + Placebo evening for 10 weeks.
  • Active Comparator: Linagliptin
    Linagliptin 5 mg x 1, morning, for 2 weeks, then Linagliptin 5 mg morning + Placebo evening for 10 weeks.
  • Active Comparator: Pioglitazone
    Pioglitazone 30 mg x 1, morning, for 2 weeks, then Pioglitazone 30 mg morning + Placebo evening for 10 weeks.

Primary Outcome Measure

Endogenous glucose production during fasting [ Time Frame: After 12 weeks on respective drugs ]

Central Contacts

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