MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00103857
First received: February 15, 2005
Last updated: April 7, 2010
Last verified: April 2010
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Purpose
The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily) Drug: Comparator: Placebo (Phase A)/Metformin (Phase B) Drug: Comparator: Metformin 500 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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Merck:
Primary Outcome Measures:
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Secondary Outcome Measures:
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 [ Time Frame: Week 24 ] [ Designated as safety issue: No ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]Change from baseline at Week 54 is defined as Week 54 minus Week 0.
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54 [ Time Frame: Week 54 ] [ Designated as safety issue: No ]Change from baseline at Week 54 is defined as Week 54 minus Week 0.
- Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]Change from baseline at Week 104 is defined as Week 104 minus Week 0.
- Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104 [ Time Frame: Week 104 ] [ Designated as safety issue: No ]Change from baseline at Week 104 is defined as Week 104 minus Week 0.
| Enrollment: | 1208 |
| Study Start Date: | March 2005 |
| Study Completion Date: | February 2008 |
| Primary Completion Date: | July 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MK0431 100 mg q.d.
|
Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily)
MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) 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.
|
|
Active Comparator: 2
Metformin 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. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) 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.
|
|
Active Comparator: 3
Metformin 1000 mg b.i.d.
|
Drug: Comparator: Metformin 1000 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) 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.
|
|
Experimental: 4
Coadministration of MK0431 and Metformin 50/500 mg b.i.d.
|
Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) 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.
Other Name: MK0431
Drug: Comparator: Metformin 500 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) 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.
|
|
Experimental: 5
Coadministration of MK0431 and Metformin 50/1000 mg b.i.d.
|
Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily)
MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) 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.
Other Name: MK0431
Drug: Comparator: Metformin 1000 mg b.i.d.
Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) 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.
|
|
Placebo Comparator: 6
Placebo/Metformin 1000 mg b.i.d.
|
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. (q.d. = once daily) 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. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks.
|
|
Experimental: 7
Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
|
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. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) 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 treatment period is 24 weeks.
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- Patients who complete the 54-week base study are eligible to enter the 50-week extension study
Exclusion Criteria:
- Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00103857 History of Changes |
| Other Study ID Numbers: | 2005_003, MK0431-036 |
| Study First Received: | February 15, 2005 |
| Results First Received: | February 19, 2009 |
| Last Updated: | April 7, 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 16, 2013