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Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)

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ClinicalTrials.gov Identifier: NCT00875394
Recruitment Status : Completed
First Posted : April 3, 2009
Results First Posted : April 20, 2011
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Tracking Information
First Submitted Date  ICMJE April 1, 2009
First Posted Date  ICMJE April 3, 2009
Results First Submitted Date  ICMJE June 12, 2009
Results First Posted Date  ICMJE April 20, 2011
Last Update Posted Date May 30, 2017
Actual Study Start Date  ICMJE February 1, 2007
Actual Primary Completion Date June 27, 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 22, 2011)
Change From Baseline in Glycosylated Hemoglobin A1C (A1C) at Week 24 [ Time Frame: Baseline and 24 weeks ]
Week 24 A1C minus baseline (Week 0) A1C. The unit for A1C is "percent". Thus, this measure represents a difference of percent values.
Original Primary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
safety and tolerability of sitagliptin co-administered with metformin over 24 weeks of treatment. [ Time Frame: over 24 weeks ]
Change History Complete list of historical versions of study NCT00875394 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: April 2, 2009)
the proportion of patients achieving glycemic goal (A1C < 6.5%) treated with sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy [ Time Frame: 24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Metformin (0431-189)
Official Title  ICMJE A Multicenter, Randomized, Open-label Study to Assess the Efficacy and Safety of Sitagliptin Added to the Regimen of Patients With T2 DM With Inadequate Glycemic Control on Metformin
Brief Summary After 24 weeks of treatment, to assess the A1C-lowering efficacy of sitagliptin 100 mg once daily added to the regimen of patients with inadequate glycemic control on metformin monotherapy
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Non-Insulin-Dependent
Intervention  ICMJE
  • Drug: sitagliptin phosphate
    sitagliptin 100 mg Once a day (QD) for 24 weeks
    Other Name: sitagliptin
  • Drug: Comparator: metformin
    metformin 850 mg Twice a day (BID) for 24 weeks
    Other Name: metformin
  • Drug: Comparator: metformin
    metformin 500 mg Three times a day (TID) to 850 mg Twice a day (BID), for 24 weeks
    Other Name: metformin
  • Drug: Comparator: Antidiabetic Standard of Care
    Patient can take any oral antidiabetic drug (other than metformin)
Study Arms  ICMJE
  • Experimental: 1
    sitagliptin + metformin
    Interventions:
    • Drug: sitagliptin phosphate
    • Drug: Comparator: metformin
  • Active Comparator: 2
    metformin + any other oral antidiabetic drug
    Interventions:
    • Drug: Comparator: metformin
    • Drug: Comparator: Antidiabetic Standard of Care
  • Active Comparator: 3
    metformin
    Intervention: Drug: Comparator: metformin
Publications * Not Provided

*   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: April 2, 2009)
68
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 27, 2008
Actual Primary Completion Date June 27, 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patient Has Type 2 Diabetes Mellitus
  • Patient Is 30-78 Years Of Age On The Day Of Signing Informed Consent
  • Patient Is Currently On Metformin Therapy (1500 Mg/Day)
  • Patient Is A Male Or A Female Who Is Unlikely To Conceive, As Indicated By At Least One Yes Answer To The Following Questions: A) Patient Is A Male. B) Patient Is A Surgically Sterilized Female. C) Patient Is A Postmenopausal Female 45 Years Of Age With >2 Years Since Last Menses. D) Patient Is A Non-Sterilized Premenopausal Female And Agrees To Use An Adequate Method Of Contraception To Prevent Pregnancy Throughout The Study Starting With Visit 1 And For 14 Days After The Last Dose Of Study Medication
  • Patient Understands The Study Procedures, The Alternative Treatments Available, The Risks Involved In The Study And Voluntarily Agrees To Participate By Giving Written Informed Consent
  • Patient Has An A1c of 6.5 % - 11.0%

Exclusion Criteria:

  • Patient Has A History Of Type 1 Diabetes Mellitus Or History Of Ketoacidosis
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 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  
 
Administrative Information
NCT Number  ICMJE NCT00875394
Other Study ID Numbers  ICMJE 0431-189
2009_571
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf

http://engagezone.msd.com/ds_documentation.php

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 April 2017

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