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MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00532935
First received: September 19, 2007
Last updated: May 11, 2017
Last verified: May 2017
September 19, 2007
May 11, 2017
January 26, 2008
October 23, 2009   (Final data collection date for primary outcome measure)
Change From Baseline in A1C at Week 32 [ Time Frame: Baseline and Week 32 ]
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
Not Provided
Complete list of historical versions of study NCT00532935 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 [ Time Frame: Baseline and Week 1 ]
    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
  • Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 [ Time Frame: Baseline and Week 32 ]
    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
  • Change From Baseline in FPG at Week 32 [ Time Frame: Baseline and Week 32 ]
    Change from baseline reflects the Week 32 FPG minus the baseline FPG
  • Percent of Participants With A1C <7.0% at Week 32 [ Time Frame: Week 32 ]
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Not Provided
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MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: sitagliptin phosphate (+) metformin hydrochloride
    sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
    Other Name: Janumet
  • Drug: Comparator: pioglitazone
    pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
    Other Name: pioglitazone
  • Experimental: 1
    Sitagliptin phosphate (+) metformin hydrochloride
    Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
  • Active Comparator: 2
    pioglitazone
    Intervention: Drug: Comparator: pioglitazone
Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
517
October 23, 2009
October 23, 2009   (Final data collection date for primary outcome measure)

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
Sexes Eligible for Study: All
18 Years to 78 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
Austria,   Costa Rica,   Hungary,   Ireland,   Israel,   Korea, Republic of,   Malaysia,   Peru,   Philippines,   Poland,   Puerto Rico,   Russian Federation,   Slovenia,   Sweden,   Thailand,   Turkey,   United Kingdom,   United States
 
NCT00532935
0431A-066
2007_510
Not Provided
Not Provided
Yes

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
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
May 2017

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