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An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)

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.
 
ClinicalTrials.gov Identifier: NCT00094757
Recruitment Status : Completed
First Posted : October 25, 2004
Results First Posted : July 21, 2010
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Comparator: sitagliptin 100 mg Drug: Comparator: sitagliptin 200 mg Drug: Comparator: placebo Drug: Comparator: pioglitazone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Actual Study Start Date : October 6, 2004
Actual Primary Completion Date : August 17, 2005
Actual Study Completion Date : April 28, 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sitagliptin 100 mg
Sitagliptin 100 mg
Drug: Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks

Experimental: Sitagliptin 200 mg
Sitagliptin 200 mg
Drug: Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks

Placebo Comparator: Placebo/Pioglitazone
Placebo/Pioglitazone
Drug: Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)

Drug: Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)




Primary Outcome Measures :
  1. Change From Baseline in A1C at Week 18 [ Time Frame: Weeks 0-18 ]
    Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.


Secondary Outcome Measures :
  1. Change From Baseline in FPG at Week 18 [ Time Frame: Weeks 0-18 ]
    The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.

  2. Change From Baseline in A1C at Week 54 [ Time Frame: Weeks 0-54 ]
    A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.

  3. Change From Baseline in FPG at Week 54 [ Time Frame: Weeks 0-54 ]
    The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients at least 18 years of age and not older than 75 who have a specific type of diabetes called Type 2 Diabetes Mellitus

Exclusion Criteria:

  • Younger than 18 years of age or older than 75
  • Any condition, which in the opinion of the investigator, may not be in the patient's best interest to participate

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): NCT00094757


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Additional Information:
Publications:
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00094757    
Other Study ID Numbers: 0431-023
2004_045
First Posted: October 25, 2004    Key Record Dates
Results First Posted: July 21, 2010
Last Update Posted: May 30, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
URL: http://engagezone.msd.com/ds_documentation.php
Additional relevant MeSH terms:
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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