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Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00087516
First received: July 9, 2004
Last updated: May 10, 2010
Last verified: May 2010
History of Changes
  Purpose

The purpose of this clinical study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Sitagliptin (MK0431)
Drug: Sitagliptin
Drug: Placebo
Drug: Metformin - Rescue
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of MK0431 Monotherapy in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Change From Baseline in A1C at Week 24 [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.


Secondary Outcome Measures:
  • Change From Baseline in FPG at Week 24 [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.

  • Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 [ Time Frame: Weeks 0-24 ] [ Designated as safety issue: No ]
    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.

  • Change From Baseline in A1C at Week 104 [ Time Frame: Weeks 0-104 ] [ Designated as safety issue: No ]
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.

  • Change From Baseline in FPG at Week 104 [ Time Frame: Weeks 0-104 ] [ Designated as safety issue: No ]
    Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.

  • Change From Baseline in 2-hr PMG at Week 104 [ Time Frame: Weeks 0-104 ] [ Designated as safety issue: No ]
    Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.


Enrollment: 741
Study Start Date: June 2004
Study Completion Date: February 2007
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Sitagliptin 100 mg/100 mg
Phase A and B: Oral tablets of sitagliptin 100 mg Once a Day (q.d )
 Drug: Sitagliptin (MK0431)
Phase A: Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Other Names:
  • MK0431
  • Januvia
Drug: Metformin - Rescue
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other Names:
  • Metformin
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Fortamet
  • Riomet
Active Comparator: Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
 Drug: Sitagliptin
Phase A: Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Other Names:
  • MK0431
  • Januvia
Drug: Metformin - Rescue
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other Names:
  • Metformin
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Fortamet
  • Riomet
Placebo Comparator: Placebo/Sitagliptin 100 mg
Phase A: Oral tablets of placebo matching sitagliptin 100 mg q.d. Phase B: Oral tablets of sitagliptin 100 mg q.d.
 Drug: Placebo
Phase A: Placebo matching Sitagliptin 100 mg once a day for 24 weeks. Phase B: Sitagliptin 100 mg once a day for 80 weeks.
Drug: Metformin - Rescue
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other Names:
  • Metformin
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Fortamet
  • Riomet
Placebo Comparator: Placebo/Sitagliptin 200 mg
Phase A: Oral tablets of placebo matching sitagliptin 200 mg q.d. Phase B: Oral tablets of sitagliptin 200 mg q.d.
 Drug: Placebo
Phase A: Placebo matching Sitagliptin 200 mg once a day for 24 weeks. Phase B: Sitagliptin 200 mg once a day for 80 weeks.
Drug: Metformin - Rescue
Phase A: Patients not meeting specific glycemic goals will receive open-label metformin as 500 mg, 850 mg, and 1000 mg oral tablets titrated at the discretion of the investigator. Phase B: These patients will not initiate Phase B double-blind medication.
Other Names:
  • Metformin
  • Glucophage
  • Glucophage XR
  • Glumetza
  • Fortamet
  • Riomet

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with type 2 diabetes mellitus
  • Patient is not pregnant or breastfeeding
  • Male or female patient unlikely to conceive
  • Patient not on an antihyperglycemic drug

Exclusion Criteria:

  • Patient has history of type 1 diabetes mellitus
  • Patient has history of ketoacidosis
  • Patient requires insulin within 8 weeks prior to start of study
  • Patient on weight loss program and is not in maintenance phase
  • Patient taking weight loss medication within 8 weeks prior to start of study
  • Patient on or likely to require = 14 days or repeated courses of corticosteroids
  • Patient taking immunosuppressive/immunomodulating medication
  • Patient taking digoxin or other cardiac medication
  • Patient has undergone surgical general anesthesia within 30 days prior to start of study
  • Patient taking investigational drug within 8 weeks prior to start of study
  • Patient is diagnosed with liver disease
  • Patient has chronic myopathy, progressive neurological/neuromuscular disorder
  • Patient has with severe cardiac conditions within the last 6 months
  • Patient is Human immunodeficiency virus (HIV) positive
  • Patient has hematological disorder
  • Patient has history of malignancy
  • Patient has history of alcohol or drug abuse within the past 3 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00087516

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00087516     History of Changes
Other Study ID Numbers: 2006_413, Formally-C0604MT2D, MK0431-021
Study First Received: July 9, 2004
Results First Received: May 10, 2010
Last Updated: May 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Metformin
 Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 22, 2013