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

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ClinicalTrials.gov Identifier: NCT00087516
Recruitment Status : Completed
First Posted : July 13, 2004
Results First Posted : June 8, 2010
Last Update Posted : July 3, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Sitagliptin (MK0431) Drug: Sitagliptin Drug: Placebo Drug: Metformin - Rescue Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 741 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : June 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : February 2007

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change From Baseline in A1C at Week 24 [ Time Frame: Weeks 0-24 ]
    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 :
  1. Change From Baseline in FPG at Week 24 [ Time Frame: Weeks 0-24 ]
    Change from baseline at Week 24 is defined as Week 24 FPG minus Week 0 FPG.

  2. Change From Baseline in 2-hour Post-meal Glucose (2-hr PMG) at Week 24 [ Time Frame: Weeks 0-24 ]
    Change from baseline at Week 24 is defined as Week 24 2-hr PMG minus Week 0 2-hr PMG.

  3. Change From Baseline in A1C at Week 104 [ Time Frame: Weeks 0-104 ]
    A1C is measured as a percent. Thus, this change from baseline reflects the Week 104 A1C percent minus the Week 0 A1C percent.

  4. Change From Baseline in FPG at Week 104 [ Time Frame: Weeks 0-104 ]
    Change from baseline at Week 104 is defined as Week 104 FPG minus Week 0 FPG.

  5. Change From Baseline in 2-hr PMG at Week 104 [ Time Frame: Weeks 0-104 ]
    Change from baseline at Week 104 is defined as Week 104 2-hr PMG minus Week 0 2-hr PMG.


Eligibility Criteria
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Information from the National Library of Medicine

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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 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
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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): NCT00087516


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

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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
First Posted: July 13, 2004    Key Record Dates
Results First Posted: June 8, 2010
Last Update Posted: July 3, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
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