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| Sponsored by: |
Merck |
|---|---|
| Information provided by: | Merck |
| ClinicalTrials.gov Identifier: | NCT00103857 |
Purpose
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (a specific type of diabetes).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Comparator: Metformin 500 mg b.i.d. Drug: Comparator: MK0431 100 mg q.d. Drug: Comparator: Placebo (Phase A)/Metformin (Phase B) Drug: Comparator: MK0431 50 mg b.i.d. Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d. Drug: Comparator: Metformin 1000 mg b.i.d. |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Factorial Assignment, Safety/Efficacy Study |
| Official Title: | A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control |
| Enrollment: | 1200 |
| Study Start Date: | March 2005 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | February 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
MK0431 100 mg q.d.
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Drug: Comparator: MK0431 100 mg q.d.
MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (i.e. 100 mg q.d.) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
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2: Active Comparator
Metformin 500 mg b.i.d.
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Drug: Comparator: Metformin 500 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased after 1 week to a stable dose of 500 mg b.i.d. Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
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3: Active Comparator
Metformin 1000 mg b.i.d.
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Drug: Comparator: Metformin 1000 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
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4: Experimental
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
|
Drug: Comparator: Metformin 500 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased after 1 week to a stable dose of 500 mg b.i.d. Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Drug: Comparator: MK0431 50 mg b.i.d.
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. and increased after one week to a stable dose of 50 mg b.i.d. Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
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5: Experimental
Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
|
Drug: Comparator: MK0431 50 mg b.i.d.
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. and increased after one week to a stable dose of 50 mg b.i.d. Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Drug: Comparator: Metformin 1000 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
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6: Placebo Comparator
Placebo/Metformin 1000 mg b.i.d.
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Drug: Comparator: Placebo (Phase A)/Metformin (Phase B)
During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. for a total placebo/metformin treatment duration of up to 104 weeks.
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7: Experimental
Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
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Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d.
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. and increased after one week to a stable dose of 50 mg b.i.d. Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatmentTreatment period is 24 weeks.
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Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
54-Week Base Study:
Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
50-Week Extension Study:
Exclusion Criteria:
Contacts and Locations More Information
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2005_003 |
| Study First Received: | February 15, 2005 |
| Last Updated: | January 26, 2009 |
| ClinicalTrials.gov Identifier: | NCT00103857 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder Protease Inhibitors Sitagliptin |
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Metabolic Diseases Molecular Mechanisms of Pharmacological Action Metformin Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Enzyme Inhibitors |
Pharmacologic Actions Sitagliptin Protease Inhibitors Dipeptidyl-Peptidase IV Inhibitors Hypoglycemic Agents Diabetes Mellitus, Type 2 Glucose Metabolism Disorders |
