MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Treatments: Drug: Placebo; Drug: MK-0941

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754130

MK-0941-011 (Other Identifier)

0941-011

2008_023 (Other Identifier)

Details and patient eligibility

About

The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.

Enrollment: 16 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Japanese Male or Female between 20 to 65 years of age
• Diagnosis of Type 2 Diabetes
• Patient being treated by diet and exercise alone

Exclusion criteria

• Patient has a history of Type 1 Diabetes
• Patient is being treated with glaucoma medications
• Patient has donated blood or participated in another clinical study in the past 12 weeks
• Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 6 patient groups

Placebo/MK-0941 20mg

Experimental group

Description:

Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941

Drug: Placebo

MK-0941 5mg/Placebo

Experimental group

Description:

Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941

Drug: Placebo

MK-0941 5mg/MK-0941 20mg

Experimental group

Description:

Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941

Placebo/MK-0941 40mg

Experimental group

Description:

Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941

Drug: Placebo

MK-0941 10mg/Placebo

Experimental group

Description:

Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941

Drug: Placebo

MK-0941 10mg/MK-0941 40mg

Experimental group

Description:

Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.

Treatment:

Drug: MK-0941