MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Placebo; Drug: MK-1006

Study type: Interventional

Funder types: Industry

Identifiers

NCT00791661

2008_584

1006-005

Details and patient eligibility

About

A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.

Enrollment: 24 patients

Sex: All

Ages: 20 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese male or female between 20 to 64 years of age
• Diagnosis of type 2 diabetes
• Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent

Exclusion criteria

• Subject has a history of type 1 diabetes mellitus
• Subject has a clinical diagnosis of glaucoma
• Subject has donated blood or participated in another clinical study in the past 12 weeks
• Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups

Panel A: MK-1006 15/30/45

Experimental group

Description:

Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Treatment:

Drug: Placebo

Drug: MK-1006

Panel B: MK-1006 60/80/60 fed

Experimental group

Description:

Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Treatment:

Drug: Placebo

Drug: MK-1006

Panel C: MK-1006 100/140/170

Experimental group

Description:

Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.

Treatment:

Drug: Placebo

Drug: MK-1006