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Report for Clinical Trial NCT04192292

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Study of Sulphonylurea Synergy With DPP4 Inhibitors

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.

NCT04192292 Type 2 Diabetes

2 Interventions

Name: Sulfonylurea

Description: Given at very low dose as a physiological stimulus on the beta cell not as medical treatment. 20mg gliclazide is being used in this study.
Type: Drug
Group Labels: 2

Low dose sulphonylurea + DPP4 inhibitor Low dose sulphonylurea alone

Name: DPP4 Inhibitor

Description: Given as a physiological stimulus to augment endogenous incretin hormone levels, not as a medical treatment. 100mg sitagliptin is being used in this study.
Type: Drug
Group Labels: 2

DPP4 inhibitor alone Low dose sulphonylurea + DPP4 inhibitor


Primary Outcomes

Description: Comparison of four mixed meal tests performed at the end of each intervention block. Meal tests will evaluate 1) No intervention 2) Low dose sulphonylurea alone 3) DPP4 inhibitor alone 4) Low dose sulphonylurea + DPP4 inhibitor. Measures of the incretin effect will be compared between the different blocks.

Measure: Difference in incretin effect between mixed meal tests

Time: Through four mixed meal tests which take place at the end of each 14 day intervention block. The four intervention blocks will be completed during an 8 week clinical phase of study.

Secondary Outcomes

Description: Difference in insulin secretory response to low dose gliclazide calculated by insulin/cpeptide levels in each meal test visit. Differences will then be compared by participants genotype e.g. insulin secretory response for E23K, E23E, K23K variants.

Measure: Insulin secretory response analysed by KCNJ11 genotype

Time: Through 4 meal test visits completed over an 8 week clinical phase of study. Outcome will also be evaluated through variability of glucose levels observed on continuous glucose monitoring worn for duration of 8 week clinical phase.

Description: Comparison time-in-range of blood sugars as low, target and high on continuous glucose monitoring between each intervention block

Measure: Variation in blood glucose during intervention blocks analysed by continuous glucose monitoring

Time: Meansurements taken via continuous glucose monitoring sensors worn by participants for duration of 8 week clinical phase

Purpose: Basic Science

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 E23K

insulin secretory response for E23K, E23E, K23K variants.. Variation in blood glucose during intervention blocks analysed by continuous glucose monitoring. --- E23K ---



HPO Nodes