MK-3102 in T2DM with Chronic Kidney Disease/ Failure on Dialysis
Research type
Research Study
Full title
A Phase III, Multicentre, Randomised, Double-Blind Study to Evaluate the Efficacy and Safety of MK-3102 Versus Placebo in Subjects with Type 2 Diabetes Mellitus with Moderate or Severe Chronic Kidney Disease or Kidney Failure on Dialysis Who Have Inadequate Glycaemic Control
IRAS ID
150684
Contact name
Ponnusamy Saravanan
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2012-002332-85
Clinicaltrials.gov Identifier
Research summary
Type 2 diabetes mellitus (T2DM) is a metabolic disorder that is characterised by increased blood sugar levels. T2DM develops when the body does not produce enough insulin (a hormone that lowers blood sugar) or is unable to properly use the insulin that is being produced. In addition, the secretion of glucagon (a hormone that increases blood sugar levels) is not appropriately regulated. Diabetes is among the leading causes of chronic kidney disease (CKD) and renal failure requiring dialysis.
Current treatment for T2DM includes diet and exercise, antihyperglycaemic (AHA) medications, and/or insulin injections. Patients with T2DM and CKD are often less able to tolerate certain AHA medications compared to patients with normal renal function.
The study drug MK-3102 is an AHA, more specifically a DPP-4 (dipeptidyl-peptidase-4) inhibitor, which improves blood sugar control in patients with T2DM by increasing insulin secretion and inhibiting glucagon secretion via incretins (gut-derived hormones). MK-3102 is dosed once per week, which may be a good option in patients with T2DM and CKD who often take multiple medications daily.
Merck Sharp & Dohme Corp is sponsoring a study to collect information on whether weekly treatment of MK-3102 is safe and effective in patients with T2DM and moderate or severe renal insufficiency or end stage renal disease (ESRD) on dialysis.
This multicentre study will last for up to 69 weeks and it will require about 12 visits to study centre. It includes a 54-week
double-blind treatment period, which is subdivided in a 24-week Phase A and a 30-week Phase B. Approximately 210 patients worldwide will be randomly assigned MK-3102 or placebo (1:1 ratio) in Phase A. Patients who received placebo in Phase A and are not on background insulin therapy will be given Glipizide (registered AHA medication) in Phase B. Neither the patient nor the study doctor will know which medication is being given.REC name
West of Scotland REC 1
REC reference
14/WS/0108
Date of REC Opinion
2 Jul 2014
REC opinion
Further Information Favourable Opinion