MK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus


Tracking Information

Start Date  ICMJESeptember 2008
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE 
 (submitted: October 26, 2009)		Evaluate the change from baseline HbA1c (Hemoglobin A1c) Sitagliptin/Pioglitazone combination compared with Pioglitazone monotherapy & Sitagliptin monotherapy at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJE 
 (submitted: July 24, 2008)		Test the safety and efficacy of the co-administration of sitagliptin and pioglitazone compared to sitagliptin monotherapy and pioglitazone monotherapy on HbA1c [ Time Frame: Efficacy at 24 weeks, Safety at 54 weeks ] [ Designated as safety issue: Yes ]
Change HistoryComplete list of historical versions of study NCT00722371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: October 26, 2009)
  • Change from Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
  • Change from Baseline in HbA1c (Hemoglobin A1C) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • Change from Baseline in FPG (Fasting Plasma Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
  • Change from Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures  ICMJE 
 (submitted: July 24, 2008)		HbA1c, 2-hour postprandial glucose, and fasting plasma glucose [ Time Frame: 24 and 54 weeks ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title  ICMJEMK0431 and Pioglitazone Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJEA Multicenter, Randomized, Double-Blind Study of the Co-Administration of Sitagliptin and Pioglitazone in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary

A study to evaluate the efficacy and safety of sitagliptin and pioglitazone co-administration in comparison with sitagliptin and pioglitazone monotherapy in patients with type 2 diabetes

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study
Condition  ICMJEType 2 Diabetes Mellitus
Intervention  ICMJE
  • Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate
    Arm 1: sitagliptin 100mg tablets or Pbo + pioglitazone 15mg tablets or capsules or Pbo Arm 2: sitagliptin 100mg tablets + pioglitazone 30mg tablets or capsules or Pbo Arm 3: sitagliptin 100mg tablets + pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
    Other Name: JANUVIA(TM)
  • Drug: Comparator: pioglitazone hydrochloride
    Arm 4: pioglitazone 15mg tablets or capsules or Pbo. Arm 5: pioglitazone 30mg tablets or capsules or Pbo. Arm 6: pioglitazone 45mg tablets or capsules or Pbo. Taken once daily for a treatment period of 54 weeks.
  • Drug: Comparator: sitagliptin phosphate
    sitagliptin 100mg tablets or Pbo taken once daily for a treatment period of 54 weeks.
    Other Name: JANUVIA (TM)
Study Arms / Comparison Groups
  • 1: Experimental
    sitagliptin/Pbo; pioglitazone/Pbo.
    Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate
  • 2: Experimental
    sitagliptin/Pbo; pioglitazone/Pbo
    Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate
  • 3: Experimental
    sitagliptin/Pbo; pioglitazone/Pbo
    Intervention: Drug: Comparator: pioglitazone hydrochloride (+) sitagliptin phosphate
  • 4: Active Comparator
    pioglitazone/Pbo
    Intervention: Drug: Comparator: pioglitazone hydrochloride
  • 5: Active Comparator
    pioglitazone/Pbo
    Intervention: Drug: Comparator: pioglitazone hydrochloride
  • 6: Active Comparator
    pioglitazone/Pbo
    Intervention: Drug: Comparator: pioglitazone hydrochloride
  • 7: Experimental
    sitagliptin/Pbo
    Intervention: Drug: Comparator: sitagliptin phosphate

Recruitment Information

Estimated Enrollment  ICMJE1295
Estimated Completion DateApril 2011
Estimated Primary Completion DateSeptember 2010   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient is is highly unlikely to conceive
  • Patient is naïve to all AHA therapies
  • Patient has T2DM.and is >=18 and <= 78 years of age on day of signing informed consent

Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient has previously been treated with insulin, TZD (rosiglitazone or pioglitazone), any DPP-4 inhibitor (sitagliptin, vildagliptin, or alogliptin), exenatide or has previously been in a clinical study with any DPP-4 inhibitor or incretin mimetic
  • Patient is on a weight loss program and is not in the maintenance phase or has started a weight loss medication (e.g. orlistat or sibutramine) within the prior 8 weeks
  • Patient has undergone surgery within the prior 30 days or has major surgery planned during the study
  • Patient has a medical history of active liver disease including chronic active hepatitis B or C or symptomatic gallbladder disease including primary biliary cirrhosis
GenderBoth
Ages18 Years to 78 Years
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: Toll Free Number1-888-577-8839
Location Countries  ICMJEUnited States,   Australia,   Austria,   Chile,   Costa Rica,   Croatia,   Greece,   Italy,   Mexico,   Peru,   Philippines,   Russian Federation,   Saudi Arabia,   Serbia,   Slovenia,   South Africa,   Taiwan,   Turkey

Administrative Information

NCT ID  ICMJENCT00722371
Responsible PartyExecutive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.
Study ID Numbers  ICMJE2008_522, MK0431-102
Study Sponsor  ICMJEMerck
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Medical MonitorMerck
Information Provided ByMerck