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Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00086515
Recruitment Status : Completed
First Posted : July 5, 2004
Results First Posted : December 17, 2010
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE July 2, 2004
First Posted Date  ICMJE July 5, 2004
Results First Submitted Date  ICMJE November 19, 2010
Results First Posted Date  ICMJE December 17, 2010
Last Update Posted Date May 5, 2017
Actual Study Start Date  ICMJE June 30, 2004
Actual Primary Completion Date July 20, 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
Change From Baseline in Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and Week 24 ]
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2015)
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline at Week 24 is defined as FPG at Week 24 minus FPG at Week 0.
  • Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24 [ Time Frame: Baseline and Week 24 ]
    Change from baseline at Week 24 is defined as PMG at Week 24 minus PMG at Week 0.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
Official Title  ICMJE A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
Brief Summary The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type II
Intervention  ICMJE
  • Drug: Sitagliptin (MK0431)
    Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
    Other Names:
    • MK0431
    • sitagliptin phosphate
    • Januvia
  • Drug: Placebo/Glipizide 5 mg
    Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
  • Drug: Metformin
    Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
  • Drug: Pioglitazone
    Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period [Phase A], from Visit 5 (Week 6) to Visit 8 (Week 24)
    Other Name: ACTOS
Study Arms  ICMJE
  • Experimental: Sitagliptin 100 mg
    The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
    Interventions:
    • Drug: Sitagliptin (MK0431)
    • Drug: Metformin
    • Drug: Pioglitazone
  • Placebo Comparator: Placebo / Glipizide 5 mg
    The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
    Interventions:
    • Drug: Placebo/Glipizide 5 mg
    • Drug: Metformin
    • Drug: Pioglitazone
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 19, 2010)
701
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE February 2, 2007
Actual Primary Completion Date July 20, 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 78 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT00086515
Other Study ID Numbers  ICMJE 0431-020
Formally-B0604T2DMT
2006_411
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Merck Sharp & Dohme Corp.
Study Sponsor  ICMJE Merck Sharp & Dohme Corp.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
PRS Account Merck Sharp & Dohme Corp.
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP