drugset / Trial / NCT04662866

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.

Timeline

Start
2021-02-10
Primary completion
2022-12
Completion
2023-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Empagliflozin Small molecule 10 mg Oral
Comparator Linagliptin Small molecule 5 mg Oral
Comparator Metformin Small molecule 500 mg Oral
Comparator Pioglitazone Small molecule 30 mg Oral

Indications