A Phase III Comparator Study in Elderly Patients with Type 2 Diabetes
Research type
Research Study
Full title
A Phase III, Multicenter, Double-Blind, Randomized, Active-Controlled Study to Evaluate the Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control
IRAS ID
61104
Contact name
Mark Blagden
Sponsor organisation
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
Eudract number
2010-020234-26
Clinicaltrials.gov Identifier
Research summary
Insulin is a hormone that is produced by the pancreas and helps the body to use glucose from the blood for energy. Type 2 Diabetes Mellitus (T2DM) develops when the body is unable to utilize insulin appropriately in the face of inadequate insulin production and increasing amounts of glucose production from the liver; this results in increasing glucose levels in the blood and the development of the symptoms of T2DM like fatigue, thirst or increased urination, as well as long-term complications including damage to small blood vessels at the back of the eye that can impair vision (retinopathy), damage to the blood vessels in the kidney that can lead to kidney failure (nephropathy), and damage to nerves that can affect numerous functions (neuropathy).Glimepiride is a commonly used treatment for T2DM that stimulates the release of insulin from the pancreas. Glimepiride is used in elderly patients with T2DM despite its potential to cause low blood sugar (hypoglycaemia). Sitagliptin is a newer medicine for T2DM that stimulates insulin secretion only when the blood glucose is high and also reduces glucose production from the liver; it has a low incidence of hypoglycaemia.The purpose of this study is to examine the safety and efficacy of sitagliptin (study drug) compared with glimepiride (comparator drug) in elderly patients (65 to 85 years of age) with T2DM and inadequate glycaemic control. Approximately 440 patients worldwide will be randomised in a 1:1 ratio to receive sitagliptin or glimepiride. Over approximately 40 weeks, patients will attend 9 visits and receive a follow-up phone call. Procedures at visits may include, but are not restricted to, blood tests, urine tests, dietary and exercise counseling and monitoring, an electrocardiogram (ECG) and measurement of vital signs. Merck Sharp & Dohme Corp. is sponsoring the study.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
10/H0505/105
Date of REC Opinion
7 Mar 2011
REC opinion
Further Information Favourable Opinion