Sitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency


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: October 26, 2009)
  • HbA1c level change from baseline to 54 weeks compared to glipizide. [ Time Frame: 54 weeks ] [ Designated as safety issue: No ]
  • Lower incidence of hypoglycemic events compared to glipizide [ 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 clinic visits every 6 weeks). [ Time Frame: 54 weeks ]
Change HistoryComplete list of historical versions of study NCT00509262 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 26, 2009)
  • Effects of sitagliptin compared with glipizide on body weight and FPG. [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]
  • Change from baseline of sitagliptin on HbA1c [ Time Frame: over 54 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: July 27, 2007)		Lower incidence of hypoglycemic events [ Time Frame: Over 54 weeks ]

Descriptive Information

Brief Title  ICMJESitagliptin vs Glipizide in Patients With Type 2 Diabetes Mellitus and Chronic Renal Insufficiency
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 Chronic Renal Insufficiency Who Have Inadequate Glycemic Control
Brief Summary

The purpose of the study is to compare how sitagliptin and glipizide lower blood glucose levels in patients with moderate and severe renal insufficiency.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJE
  • Type 2 Diabetes Mellitus
  • Renal Insufficiency, Chronic
Intervention  ICMJE
  • Drug: Comparator: sitagliptin phosphate
    sitagliptin phosphate 25mg tablets for up to a 54-wk treatment period
  • Drug: Comparator: Comparator: Placebo (unspecified)
    glipizide Pbo scored tablet qd, for up to a 54-wk treatment period.
  • Drug: Comparator: Comparator: Placebo (unspecified)
    sitagliptin Pbo 25mg tablets, for up to a 54-wk treatment period
  • Drug: Comparator: Comparator: glipizide
    glipizide 2.5mg scored tablet, titrating up to 10mg bid for up to a 54-wk treatment period
Study Arms / Comparison Groups
  • 1: Placebo Comparator
    Arm 1: drug + Pbo comparator
    Interventions:
    • Drug: Comparator: sitagliptin phosphate
    • Drug: Comparator: Comparator: Placebo (unspecified)
    • Drug: Comparator: Comparator: Placebo (unspecified)
  • 2: Placebo Comparator
    Arm 2: drug + Pbo comparator
    Interventions:
    • Drug: Comparator: sitagliptin phosphate
    • Drug: Comparator: Comparator: Placebo (unspecified)
    • Drug: Comparator: Comparator: Placebo (unspecified)
  • 3: Active Comparator
    Arm 3: Active comparator
    Intervention: Drug: Comparator: Comparator: glipizide

Recruitment Information

Estimated Enrollment  ICMJE500
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 has moderate or severe renal insufficiency

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 is on dialysis or is likely to need dialysis during the study
GenderBoth
Ages30 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Chile,   Colombia,   France,   Germany,   Hong Kong,   India,   Israel,   Malaysia,   Mexico,   Philippines,   Russian Federation,   Sweden,   Thailand

Administrative Information

NCT ID  ICMJENCT00509262
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2007_549, MK0431-063
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck