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MK0431 (Sitagliptin) Pioglitazone Add-on Study for Patients With Type 2 Diabetes Mellitus (0431-055)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00372060
Recruitment Status : Completed
First Posted : September 6, 2006
Results First Posted : March 31, 2009
Last Update Posted : May 12, 2017
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The clinical study determines the safety and efficacy of MK0431 in patients with type 2 diabetes mellitus who have inadequate glycemic control on pioglitazone as monotherapy.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: sitagliptin phosphate Drug: Comparator: sitagliptin phosphate (MK0431) Drug: Comparator: pioglitazone Drug: Comparator: placebo (unspecified) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: MK0431 (Sitagliptin) Phase III Clinical Study -Pioglitazone add-on Study for Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : August 21, 2006
Primary Completion Date : February 5, 2008
Study Completion Date : February 5, 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: 1
MK0431 + pioglitazone
Drug: sitagliptin phosphate
Sitagliptin (MK0431) 50 or 100 mg once daily for 52 weeks
Other Name: MK0431
Drug: Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Placebo Comparator: 2
Placebo/MK0431 + pioglitazone
Drug: Comparator: sitagliptin phosphate (MK0431)
Sitagliptin (MK0431) 50 or 100 mg once daily for 40 weeks
Other Name: MK0431
Drug: Comparator: pioglitazone
pioglitazone once daily for 52 weeks
Drug: Comparator: placebo (unspecified)
Placebo once daily for 12 weeks



Primary Outcome Measures :
  1. Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 12 [ Time Frame: 12 Weeks ]
    Change from the baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.


Secondary Outcome Measures :
  1. Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: 12 Weeks ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.


Other Outcome Measures:
  1. Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: 12 weeks ]
    Change from baseline measurement, where the baseline measurement was obtained at randomization (0 week) before receiving study medication.

  2. Change From Baseline in Hemoglobin A1c (HbA1c ) at Week 52 [ Time Frame: Week 52 (reflecting change from Week 0) for Sitagliptin/Sitagliptin group; Weeks 52 (reflecting change from Week 12) for Placebo/Sitagliptin group. ]
    Change from the last value before receiving sitagliptin therapy: Week 0 for Sitagliptin/Sitagliptin group and Week 12 for the Placebo/Sitagliptin group.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients Have Type 2 Diabetes Mellitus
  • On Diet/Exercise Therapy And Pioglitazone As Monotherapy

Exclusion Criteria:

  • Patients Have Type 1 Diabetes Mellitus

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): NCT00372060


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

Additional Information:
Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00372060     History of Changes
Other Study ID Numbers: 0431-055
2006_029
First Posted: September 6, 2006    Key Record Dates
Results First Posted: March 31, 2009
Last Update Posted: May 12, 2017
Last Verified: April 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
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