MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Merck
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00289848
First received: February 7, 2006
Last updated: March 18, 2010
Last verified: March 2010
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Purpose
This is a clinical study to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Type 2 Diabetes Mellitus |
Drug: sitagliptin phosphate Drug: Comparator: placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 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 Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
Secondary Outcome Measures:
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
- Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 [ Time Frame: Baseline and Week 18 ] [ Designated as safety issue: No ]Change from baseline at Week 18 is defined as Week 18 minus Week 0.
| Enrollment: | 530 |
| Study Start Date: | April 2006 |
| Study Completion Date: | March 2007 |
| Primary Completion Date: | March 2007 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
sitagliptin 100 mg
|
Drug: sitagliptin phosphate
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
Other Name: Januvia
|
|
Placebo Comparator: 2
placebo
|
Drug: Comparator: placebo
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients have Type 2 Diabetes Mellitus and have laboratory results that are within the values established by the study such as an Hemoglobin A1c (HbA1c) >=7.5% and <=11% and a Fasting Plasma Glucose (FPG) >=130 mg/dL and <=280 mg/dL
Exclusion Criteria :
- Patients have Type 1 Diabetes Mellitus or required insulin therapy within the past 12 months
Contacts and Locations More Information
Additional Information:
Publications:
| Responsible Party: | Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp |
| ClinicalTrials.gov Identifier: | NCT00289848 History of Changes |
| Other Study ID Numbers: | 2005_094, MK0431-040 |
| Study First Received: | February 7, 2006 |
| Results First Received: | March 18, 2010 |
| Last Updated: | March 18, 2010 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013