A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency Who Have Inadequate Glycemic Control

Active, not recruiting

• Conditions: Type II Diabetes mellitus; MedDRA version: 9.1Level: LLTClassification code 10045242Term: Type II diabetes mellitus

• Registration Number: EUCTR2007-003548-32-LT
• Lead Sponsor: Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02-19
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

?Patient has type 2 diabetes mellitus (T2DM).
?Patient has moderate or severe renal insufficiency as indicated by a creatinine clearance <50 mL/min and is not likely to require dialysis throughout the duration of the study.
?Patient is = 30 years of age on day of signing informed consent.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
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

?Patient is on dialysis or is likely to need dialysis during the study.
?Patient has type 1 diabetes mellitus or a history of ketoacidosis.
?Patient has been diagnosed with a significant cardiovascular disorder (e.g. MI or unstable angina) or has had a cardiovascular procedure (e.g. CABG or PTCA) within 3 months of signing informed consent.
?Patient has new or worsening signs or symptoms of congestive heart failure within 3 months of signing informed consent.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: After 54 weeks, to assess the effect of sitagliptin compared with glipizide on HbA1c; After 54 weeks, to assess the effect of sitagliptin compared with glipizide on the incidence of hypoglycemic events.; After 54 weeks, to assess the safety and tolerability of sitagliptin.;Secondary Objective: After 54 weeks, to assess the effect of sitagliptin compared with glipizide on body weight; After 54 weeks, to assess the effect (change from baseline) of sitagliptin on HbA1c; After 54 weeks, to assess the effect of sitagliptin compared with glipizide on FPG. <br><br>Exploratory objectives: After 54 weeks, to assess the effect (change from baseline) of sitagliptin compared with glipizide on blood pressure.;Primary end point(s): Efficacy: HbA1c, FPG, insulin, and proinsulin; Safety: adverse experience, blood chemistry, hematology, urinalysis, urine albumin, weight, vital signs, and ECG