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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2007-003548-32-SE
Enrollment
500
Registered
2007-08-02
Start date
2007-09-27
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type II Diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus

Interventions

Trade Name: JANUVIA Product Name: Januvia Product Code: sitagliptin Pharmaceutical Form: Tablet INN or Proposed INN: sitagliptin Current Sponsor code: MK-0431 Other descriptive name: sitagliptin Con

Sponsors

Merck Sharp & Dohme (Sweden) AB
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: ? Patient has type 2 diabetes mellitus (T2DM). ? Patient has moderate or severe renal insufficiency as indicated by a creatinine clearance =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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. 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—

Countries

Austria, France, Germany, Italy, Lithuania, Sweden

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026