Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impair… (NCT04662866) | Clinical Trial Compass
UnknownPhase 2
Effects of Glucose Lowering Agents in South Asian Women With Impaired Glucose Tolerance or Impaired Fasting Glucose
Norway64 participantsStarted 2021-02-10
Plain-language summary
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.
Who can participate
Age range18 Years – 60 Years
SexFEMALE
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Inclusion criteria
✓. Able and willing to give informed consent
✓. Woman ≥ 18 years of age
✓. Of South Asian origin
✓. Participated in the DIASA 1 study (i.e. has had previous gestational diabetes (GDM) in last pregnancy). A period of 3 months after the 3-year limit since childbirth after GDM is seen as acceptable for inclusion.
✓. Impaired glucose tolerance (2-hour glucose value ≥7.8 and \< 11.1 mmol/l) and/or impaired fasting glucose (fasting plasma glucose ≥ 6.1 and \< 7.0 mmol/l) diagnosed in DIASA 1
Exclusion criteria
✕. Known type 2 diabetes
✕. Known type 1 diabetes
✕. Fasting or 2-hour glucose values outside the inclusion criteria if the subject according to protocol needs to undergo an OGTT at baseline in DIASA 3
✕. Pregnant or fully lactating at randomisation or planned during study period.
. Not willing to practice a highly effective birth control method\* prior to initial dose, during study and for 2 weeks after the last administration of study drug.
✕. Concomitant use of any antidiabetic medication
✕. Concomitant use of fibrates or rifampicin
✕. Radiological examinations iodine containing contrast the previous week before randomisation, or planned during the study period.