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Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01545388
First Posted: March 6, 2012
Last Update Posted: April 24, 2017
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.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
March 1, 2012
March 6, 2012
February 10, 2014
March 26, 2014
April 24, 2017
February 23, 2012
March 12, 2013   (Final data collection date for primary outcome measure)
  • Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ]
    Based on a constrained longitudinal data analysis (cLDA) model with terms for treatment, other prior antihyperglycemic agent (AHA) therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.
  • Percentage of Participants Who Experienced at Least One Adverse Event [ Time Frame: Up to 26 weeks ]
  • Number of Participants Who Discontinued Study Drug Due to an Adverse Event [ Time Frame: Up to 24 weeks ]
Change from baseline to Week 24 in hemoglobin A1c (HbA1c) [ Time Frame: Baseline and Week 24 ]
Complete list of historical versions of study NCT01545388 on ClinicalTrials.gov Archive Site
Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]
Based on a cLDA model with terms for treatment, other prior AHA therapy status other than sitagliptin (yes/no), study drug regimen (just before meal/after meal), sitagliptin dosage (50 mg/100 mg), time and the interaction of time by treatment, time by other prior AHA therapy status, time by study drug regimen, time by sitagliptin dosage and study drug regimen by sitagliptin dosage, with a constraint that the mean baseline is the same for all treatment groups.
Change From Baseline to Week 24 in Fasting Plasma Glucose (FPG) [ Time Frame: Baseline and Week 24 ]
Not Provided
Not Provided
 
Metformin Add-on Regimen Comparison Study in Japanese Participants With Type 2 Diabetes Mellitus (MK-0431A-136)
A Phase III, Randomized, Placebo and Active-Controlled, Double-Blind Clinical Trial to Study the Efficacy and Safety of the Addition of Metformin in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy and Sitagliptin Monotherapy
This study will evaluate the effect of the addition of metformin once daily (q.d.) or twice daily (b.i.d.) to sitagliptin monotherapy in Japanese participants with Type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with diet/exercise therapy and sitagliptin monotherapy. The primary hypotheses are that the addition of metformin 250 mg b.i.d. or metformin 500 mg q.d. is superior to the addition of placebo on the change from baseline in hemoglobin A1c (HbA1c) at 24 weeks and that the addition of metformin 500 mg q.d. is non-inferior to the addition of metformin 250 mg b.i.d. on the change from baseline in HbA1c at 24 weeks.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: Sitagliptin
    Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)
    Other Name: MK-0431/ONO-5435
  • Drug: Metformin
    Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks
  • Drug: Metformin
    Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks
  • Drug: Placebo
    Placebo to match metformin 250 mg tablets, orally, for 24 weeks
  • Experimental: Metformin 500 mg q.d.
    Participants will receive sitagliptin daily (continuing their pre-study dose), 2 metformin 250 mg tablets in the morning and 1 matching placebo tablet in the evening.
    Interventions:
    • Drug: Sitagliptin
    • Drug: Metformin
    • Drug: Placebo
  • Experimental: Metformin 250 mg b.i.d.
    Participants will receive sitagliptin daily (continuing their pre-study dose), 1 metformin 250 mg tablet and 1 matching placebo tablet in the morning and 1 metformin 250 mg tablet in the evening.
    Interventions:
    • Drug: Sitagliptin
    • Drug: Metformin
    • Drug: Placebo
  • Placebo Comparator: Placebo
    Participants will receive sitagliptin daily (continuing their pre-study dose), 2 matching placebo tablets in the morning and 1 matching placebo tablet in the evening.
    Interventions:
    • Drug: Sitagliptin
    • Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
337
March 12, 2013
March 12, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Type 2 Diabetes Mellitus (T2DM)
  • Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 4 weeks, on any additional oral hypoglycemic agent (AHA) in the prior 8 weeks, and HbA1c ≥ 6.0% and ≤ 9.0%; or
  • Currently being treated with diet/exercise and on stable dose of sitagliptin for ≥ 10 weeks, not on any additional oral AHA in the prior 8 weeks, and HbA1c ≥ 6.5% and < 10.0%

Exclusion Criteria:

  • Type 1 diabetes mellitus,
  • Secondary diabetes mellitus, or
  • Gestational diabetes mellitus
Sexes Eligible for Study: All
20 Years to 74 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Japan
 
NCT01545388
0431A-136
ONO-5435A ( Other Identifier: ONO Pharmaceutical Company, Ltd. )
No
Not Provided
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

Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2017

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