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
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Condition or disease | Intervention/treatment | Phase |
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Diabetes Mellitus, Type 2 | Drug: Sitagliptin (MK0431) Drug: Sitagliptin Drug: Placebo Drug: Metformin - Rescue | Phase 3 |
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 |

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 )
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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:
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:
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Active Comparator: Sitagliptin 200 mg/200 mg
Phase A and B: Oral tablets of sitagliptin 200 mg q.d
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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:
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:
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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.
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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:
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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:
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- 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.
- 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.
- 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.
- 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.
- 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.
- 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.

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

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
Study Director: | Medical Monitor | Merck Sharp & Dohme LLC |
Responsible Party: | Merck Sharp & Dohme LLC |
ClinicalTrials.gov Identifier: | NCT00087516 |
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 |
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 |