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A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus

Tracking Information

Start Date ^ICMJE	March 2009
Estimated Primary Completion Date	February 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 24, 2009)	24-hour weighted mean glucose-lowering efficacy of MK3577 compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00868790 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 24, 2009)	Fasting glucose levels after evening administration of MK3577 or placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information

Brief Title ^ICMJE	A Study of the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus
Official Title ^ICMJE	A Phase IIa, Multicenter, Randomized, Placebo- and Active-Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK3577 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
Brief Summary	This study will assess the safety and efficacy of MK3577 when given in the morning, the evening, or twice a day as compared to placebo and to metformin.
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Safety/Efficacy Study
Condition ^ICMJE	Type 2 Diabetes Mellitus
Intervention ^ICMJE	Drug: MK3577 MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks. Drug: Comparator: Placebo Placebo to MK3577 tablets twice daily for 4 weeks. Drug: Comparator: MK3577. [Please post as MK3577, list in interventions field once only] MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks. Drug: Comparator: MK3577, [Please post as MK3577, list in interventions field once only] MK3577 tablets totaling 25 mg twice daily for 4 weeks. Drug: Comparator: metformin Metformin tablets 1000 mg twice daily for 4 weeks.
Study Arms / Comparison Groups	A: Placebo Comparator Placebo to MK3577 Intervention: Drug: Comparator: Placebo B: Experimental MK3577 10 mg QD AM Intervention: Drug: MK3577 C: Experimental MK3577 6 mg QD PM Intervention: Drug: Comparator: MK3577. [Please post as MK3577, list in interventions field once only] D: Experimental MK3577 25 mg BID Intervention: Drug: Comparator: MK3577, [Please post as MK3577, list in interventions field once only] E: Active Comparator Metformin 1000 mg BID Intervention: Drug: Comparator: metformin

Recruitment Information

Estimated Enrollment ^ICMJE

276

Estimated Completion Date

February 2011

Estimated Primary Completion Date

February 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient has type 2 diabetes
Patient is either not taking antihyperglycemic medications for the last 10 weeks OR is taking a single oral antihyperglycemic medication (but not a PPARg agonist) OR is taking a low-dose combination oral antihyperglycemic medication (not a PPARg agonist) at dose less than or equal to 50% of the maximum dose
Female patient is unable to have children

Exclusion Criteria:

Patient has a history of type 1 diabetes or ketoacidosis
Patient has been treated with a PPARg agonist in the last 12 weeks
Patient has been treated with insulin in the last 12 weeks
Patient has had statin therapy in the last 12 weeks
Patient is on a weight loss program that is not in the maintenance phase or has been treated with a weight loss medication in the last 8 weeks
Patient has a history of coronary artery disease
Patient has had a stroke or transient ischemic attack
Patient has congestive heart failure
Patient is HIV positive
Patient has a history of cancer except certain skin or cervical cancers
Patient is not willing to abstain from alcohol for 48 hours prior to each clinic visit
Patient is breast-feeding
Patient will donate eggs during the study

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Toll Free Number

1-888-577-8839

Location Countries ^ICMJE

United States, Colombia, Hong Kong, India, Italy, Malaysia, Mexico, Russian Federation, South Africa, Spain

Administrative Information

NCT ID ^ICMJE

NCT00868790

Responsible Party

Executive Vice President, Clinical and Quantitative Sciences, Merck & Co., Inc.

Study ID Numbers ^ICMJE

2009_564, MK3577-009

Study Sponsor ^ICMJE

Merck

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Medical Monitor

Merck

Information Provided By

Merck

Source: http://clinicaltrials.gov/