MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00289848
• Date of registration: 07/02/2006
• Primary sponsor: Merck
• Public title: MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus
• Scientific title: A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
• Date of first enrolment: April 2006
• Target sample size: 530
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00289848
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Countries of recruitment

China, India, Korea, Republic of

Contacts

• Name: Medical Monitor
• Affiliation: Merck

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Comparator: placebo

Drug: sitagliptin phosphate

Primary Outcome(s)

Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 [Time Frame: Baseline and Week 18]

Secondary Outcome(s)

Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 [Time Frame: Baseline and Week 18]

Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [Time Frame: Baseline and Week 18]

Secondary ID(s)

2005_094

MK0431-040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors