MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00482729
First received: May 31, 2007
Last updated: February 3, 2015
Last verified: February 2015
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Purpose
The purpose of this study is to investigate the efficacy and safety of an investigational treatment for type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: metformin |
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 Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM) |
Resource links provided by NLM:
Further study details as provided by Merck Sharp & Dohme Corp.:
Primary Outcome Measures:
- Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcome Measures:
- Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ] [ Designated as safety issue: No ]
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
Other Outcome Measures:
- Change From Baseline in A1C at Week 44 [ Time Frame: Baseline and Week 44 ] [ Designated as safety issue: No ]A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
- Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ] [ Designated as safety issue: No ]
| Enrollment: | 1246 |
| Study Start Date: | June 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
Arm 1: drug
|
Drug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
Other Names:
|
|
Active Comparator: 2
Arm 2: active comparator
|
Drug: metformin
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
Other Name: metformin
|
Eligibility| Ages Eligible for Study: | 18 Years to 78 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patient has type 2 diabetes mellitus
- Patient is greater than or equal to 18 and less than or equal to 78 years of age on the day of signing the consent
- Patient has Hb1Ac greater than or equal to 7.5% and is appropriate for oral therapy
- Patient has not been on any antihyperglycemic agent (AHA) in the last 4 months
- Patient is a male, or a female who is unlikely to conceive
Exclusion Criteria:
- Patient has type 1 diabetes mellitus or history of ketoacidosis
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: NCT00482729
Please refer to this study by its ClinicalTrials.gov identifier: NCT00482729
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00482729 History of Changes |
| Other Study ID Numbers: | 0431A-079, MK0431A-079, 2007_548 |
| Study First Received: | May 31, 2007 |
| Results First Received: | December 9, 2009 |
| Last Updated: | February 3, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Metformin Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015