null - FindTrial

A Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Sitagliptin Versus Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease Who Are on Dialysis and Who Have Inadequate Glycemic Control -

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2007-003529-26-DE

Enrollment

150

Registered

2007-08-13

Start date

2008-01-18

Completion date

Unknown

Last updated

2012-07-24

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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: sitagliptin Current Sponsor code: MK-0431 Concentration unit: mg milligram(s) Concentration type: equal Concentration n

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ? Patient has type 2 diabetes mellitus (T2DM). ? Patient is on dialysis (hemodialysis or peritoneal dialysis for at least 6 months) on day of signing informed consent. ? Patient is = 30 years of age on day of signing informed consent. ? Patient is likely to complete the study. 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

Exclusion criteria: ? Patient has been on dialysis for < 6 months. ? 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

Measure	Time frame
Main Objective: After 54 weeks, to assess the effect (change from baseline) of sitagliptin on HbA1c; 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 the incidence of hypoglycemic events; After 54 weeks, to assess the effect of sitagliptin compared with glipizide on HbA1c; After 54 weeks, to assess the effect (change from baseline) of sitagliptin on FPG.;Primary end point(s): Efficacy: HbA1c, FPG, insulin, and proinsulin; Safety: adverse experience, blood chemistry, hematology, urinalysis, urine albumin, weight, vital signs, and ECG	—

Measure

Time frame

Main Objective: After 54 weeks, to assess the effect (change from baseline) of sitagliptin on HbA1c; 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 the incidence of hypoglycemic events; After 54 weeks, to assess the effect of sitagliptin compared with glipizide on HbA1c; After 54 weeks, to assess the effect (change from baseline) of sitagliptin on FPG.;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

Germany

Outcome results

None listed

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