Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease


Tracking Information

Start Date  ICMJEOctober 2007
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: November 18, 2009)		HbA1c level from baseline to 54 weeks [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: July 27, 2007)		HbA1c level from baseline to 54 weeks (based on measurements at clinic visits every 6 weeks) [ Time Frame: 54 weeks ]
Change HistoryComplete list of historical versions of study NCT00509236 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: November 18, 2009)		Effect of sitagliptin compared with glipizide on hypoglycemic events, HbA1c, FPG [ Time Frame: At the end of 54 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: July 27, 2007)		A review of clinical adverse experiences, laboratory values, weight, vital signs and ECG data [ Time Frame: At the end of 54 weeks ]

Descriptive Information

Brief Title  ICMJESitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and End-Stage Renal Disease
Official Title  ICMJEA 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
Brief Summary

The purpose of the study is to compare sitagliptin and glipizide in lowering blood sugar in patients withT2DM and end-stage renal disease on dialysis

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Type 2 Diabetes Mellitus Renal Disease, End-Stage
  • Renal Disease, End-Stage
Intervention  ICMJE
  • Drug: sitagliptin phosphate
    sitagliptin phosphate 25 mg tablet, for a 54-wk treatment period
  • Drug: Comparator: Comparator: glipizide
    glipizide 2.5 mg qd, titrating up to 10 mg bid, based on glycemic control for a 54-wk treatment period
Study Arms / Comparison Groups
  • 1: Experimental
    Drug
    Intervention: Drug: sitagliptin phosphate
  • 2: Active Comparator
    Intervention: Drug: Comparator: Comparator: glipizide

Recruitment Information

Estimated Enrollment  ICMJE150
Estimated Completion DateMarch 2011
Estimated Primary Completion DateMarch 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is on dialysis

Exclusion Criteria:

  • Patient has type 1 diabetes mellitus or a history of ketoacidosis. Patient is on a new weight loss program
  • Patient has active liver disease.
  • Patient has been on dialysis for less than 6 months
GenderBoth
Ages30 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Germany,   Hong Kong,   Israel,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00509236
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2007_550, MK0431-073
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck