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

• Conditions: Type 2 diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disorders

• Registration Number: EUCTR2010-020234-26-BG
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-08
• Last Update Posted: 21 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

Patients must meet all of the following criteria to participate in the study.
At Visit 1
1.Patient is =65 and =85 years of age with T2DM and is community-dwelling.
2.Patient is not on AHA (for =12 weeks) and has an A1C of =7.0% and =9.0%.
OR
Patient is on oral AHA monotherapy or low-dose combination therapy (i.e., approximately =50% of maximum dose of each agent) and has a Visit 1 A1C of =6.5% and =8.5%.
3.Patient understands the study procedures, alternative treatments available, and a risk involved with the study, and voluntarily agrees to participate by giving written informed consent.
At Visit 2/3 or Visit 3
4.Patient has an A1C of =7.0% and =9.0%.
At Visit 4
5.Patient has ³85% compliance (as measured by tablet count) with single-blind placebo tablets during run-in.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Individuals are excluded from participation in the study if they meet any of the following criteria.
At Visit 1
Glucose Metabolism and Therapy Criteria
1.Patient has a history of type 1 diabetes mellitus (T1DM) or a history of ketoacidosis.
OR
Patient is assessed by the investigator as possibly having T1DM supported by a C-peptide <0.7 ng/mL (<0.23 nmol/L).
Note: Only patients assessed by the investigator as possibly having T1DM should have C-peptide measured at Visit 1.
2.Patient has been on an investigational or approved dipeptidyl peptidase-4 (DPP-4) inhibitor agent.
3.Patient has been on glucagon-like peptide-1 (GLP-1) analogues or mimetics (e.g., liraglutide, exenatide, etc.) or insulin within the prior 8 weeks.
4.Patient has been on a PPAR? agonist within the prior 16 weeks.
5.Patient has a hypersensitivity or contraindication to any sulfonylurea (e.g., glimepiride) medication.
Note: Hypoglycemia is not considered a hypersensitivity to a sulfonylurea medication.
Patients Receiving Specific Treatments
6.Patient is on a weight loss program and is not in the maintenance phase, or has been started on a weight loss medication (e.g., orlistat or sibutramine) within the prior 8 weeks.
7.Patient is on or likely to require treatment with =14 consecutive days or repeated courses of pharmacologic doses of corticosteroids.
Note: Inhaled, nasal, and topical corticosteroids are permitted.
8.Patient has untreated hyperthyroidism or is currently under treatment for hyperthyroidism.
9.Patient has undergone a surgical procedure within the prior 4 weeks.
Note: Patients who have undergone minor surgery within the prior 4 weeks and are fully recovered or patients who have planned minor surgery may participate. Minor surgery is defined as a surgical procedure involving local anesthesia.
10.Patient is currently participating in or has participated in another study with an investigational compound or device within the prior 12 weeks and does not agree to refrain from participating in any other study while participating in this study.
Concomitant Disease of Organs and Systems

Please refer to protocol for full list of exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: After 30 weeks, in elderly patients with T2DM with inadequate glycemic control on diet and exercise:<br><br>1) To assess the effect of sitagliptin compared with glimepiride on A1C.<br><br>2) To assess the effect of sitagliptin compared with glimepiride on the incidence of adverse events of symptomatic hypoglycemia<br><br>;Secondary Objective: To assess the effect of sitagliptin compared with glimepiride on:<br><br>(1)Body weight<br>(2)Fasting plasma glucose (FPG)<br>(3)Percentage of patients with A1C at goal (<7.0%, <6.5%)<br>;Primary end point(s): Primary Endpoint: A1C<br>Secondary Endpoint: FPG