Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-021)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00087516
First received: July 9, 2004
Last updated: June 8, 2015
Last verified: June 2015
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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:
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:
|
|
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:
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:
|
|
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:
|
|
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:
|
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Senior) |
| 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
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: | June 8, 2015 |
| 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 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 |
ClinicalTrials.gov processed this record on September 28, 2016