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

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ClinicalTrials.gov Identifier: NCT00532935
Recruitment Status : Completed
First Posted : September 21, 2007
Results First Posted : October 18, 2010
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: Comparator: pioglitazone Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 517 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : January 26, 2008
Actual Primary Completion Date : October 23, 2009
Actual Study Completion Date : October 23, 2009


Arm Intervention/treatment
Experimental: 1
Sitagliptin phosphate (+) metformin hydrochloride
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
Active Comparator: 2
pioglitazone
Drug: Comparator: pioglitazone
pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
Other Name: pioglitazone



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. Percent of Participants With A1C <7.0% at Week 32 [ Time Frame: Week 32 ]


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Ages Eligible for Study:   18 Years to 78 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532935


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Publications of Results:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00532935     History of Changes
Other Study ID Numbers: 0431A-066
2007_510
First Posted: September 21, 2007    Key Record Dates
Results First Posted: October 18, 2010
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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


Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pioglitazone
Metformin
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action