A Phase IIa, Multicenter, Randomized, Placebo- and Active- Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2009/091/000614
• Date of registration: 28-08-2009
• Primary sponsor: Merck Co Inc
• Public title: A Phase IIa, Multicenter, Randomized, Placebo- and Active- Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
• Scientific title: A Phase IIa, Multicenter, Randomized, Placebo- and Active- Comparator Controlled, Cross-Over Clinical Trial to Study the Safety and Efficacy of MK-3577 in Patients with Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
• Date of first enrolment: 19-08-2009
• Target sample size: 276
• Recruitment status: Other (Terminated)
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=810
• Study type: Interventional
• Study design: Randomized, Crossover Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Countries of recruitment

India

Contacts

• Name: Mr Anirban Roy Chowdhury
• Affiliation: .

• Name: Mr Anirban Roy Chowdhury
• Affiliation: .

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Intervention1: MK3577 10 mg QD AM: Drug: MK3577
MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks.

MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks.

MK3577 tablets totaling 25 mg twice daily for 4 weeks.

Intervention2: MK3577 25 mg BID: Drug: MK3577
MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks.

MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks.

MK3577 tablets totaling 25 mg twice daily for 4 weeks.

Intervention3: MK3577 6 mg QD PM: Drug: MK3577
MK3577 tablets totaling 10 mg once daily in the morning for 4 weeks.

MK3577 tablets totaling 6 mg once daily in the evening for 4 weeks.

MK3577 tablets totaling 25 mg twice daily for 4 weeks.

Control Intervention1: Metformin 1000 mg BID: Drug: Comparator: metformin
Metformin tablets 1000 mg twice daily for 4 weeks.
Control Intervention2: Placebo Comparator: Drug: Comparator: Placebo
Placebo to MK3577 tablets twice daily for 4 weeks.

Primary Outcome(s)

24-hour weighted mean glucose-lowering efficacy of MK3577 compared to placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]Timepoint: 4 weeks

Secondary Outcome(s)

Fasting glucose levels after evening administration of MK3577 or placebo [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Timepoint: 4 weeks

Secondary ID(s)

009-00

NCT00868790

Source(s) of Monetary Support

Merck & Co Inc. is the sponsor for the study