MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289848
First received: February 7, 2006
Last updated: May 9, 2014
Last verified: May 2014
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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 Sharp & Dohme Corp.:
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
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: NCT00289848
Please refer to this study by its ClinicalTrials.gov identifier: NCT00289848
Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
| Study Director: | Medical Monitor | Merck Sharp & Dohme Corp. |
More Information
Additional Information:
Publications:
| Responsible Party: | Merck Sharp & Dohme Corp. |
| ClinicalTrials.gov Identifier: | NCT00289848 History of Changes |
| Other Study ID Numbers: | 0431-040, MK0431-040, 2005_094 |
| Study First Received: | February 7, 2006 |
| Results First Received: | March 18, 2010 |
| Last Updated: | May 9, 2014 |
| Health Authority: | India: Ministry of Health |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Sitagliptin Dipeptidyl-Peptidase IV Inhibitors Enzyme Inhibitors |
Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Hypoglycemic Agents Incretins Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Protease Inhibitors |
ClinicalTrials.gov processed this record on February 25, 2015