Study of Sulphonylurea Synergy With DPP4 Inhibitors
Status:
Completed
Trial end date:
2020-12-02
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
University of Dundee
Treatments:
Dipeptidyl-Peptidase IV Inhibitors Gliclazide Sitagliptin Phosphate