drugset / Trial / NCT04192292

Study of Sulphonylurea Synergy With DPP4 Inhibitors

NCT04192292

Completed 30 enrolled University of Dundee
RandomizedParallel-groupOpen-labelBasic science

Summary

The Study of Sulphonylurea Synergy with DPP4 Inhibitors (SSS Study) will establish whether a very low dose of sulphonylurea will have a synergistic role on augmentation of insulin secretion when given in combination with a DPP4 inhibitor as a primary outcome. The study will recruit 30 patients with type 2 diabetes mellitus controlled with no treatment or metformin monotherapy with an HbA1c \<64mmol/mol (\<8%). In this unblinded, randomised physiological study, participants will receive four 14-day intervention blocks: low dose sulphonylurea alone, DPP4 inhibitor alone, low dose sulphonylurea + DPP4 inhibitor or no treatment change. The primary outcome will be assessed through evaulation of insulin secretion and sensitivity at mixed meal test at the end of each treatment block. Glycaemic variability on continuous glucose monitoring for each intervention block will be evaluated as a secondary outcome. In addition, the primary outcome will be evaulated for KCNJ11 genotype as an additional secondary outcome.

Timeline

Start
2019-10-08
Primary completion
2020-12-02
Completion
2020-12-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Gliclazide Small molecule 20 mg Oral
Subject Sitagliptin Small molecule 100 mg Oral