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Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00087516
First received: July 9, 2004
Last updated: May 9, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00087516

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

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00087516     History of Changes
Other Study ID Numbers: 0431-021, Formally-C0604MT2D, MK0431-021, 2006_413
Study First Received: July 9, 2004
Results First Received: May 10, 2010
Last Updated: May 9, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on November 20, 2014