A Pharmacokinetic Study of MK-0941 After Multiple Daily Doses in Subjects With Type 2 Diabetes (MK-0941-012)(COMPLETED)

Merck Sharp & Dohme (MSD)

Status and phase

Completed

Phase 1

Conditions

Diabetes Mellitus, Type 2

Treatments

Drug: MK-0941

Drug: Comparator: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00873821

0941-012

2008_533

Details and patient eligibility

About

A study to test the pharmacokinetics after twice daily administration of MK-0941 or placebo in subjects with type 2 diabetes who have inadequate control on metformin.

Enrollment

44 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has a BMI < 42 kg/m2
Subject is taking >1500 mg metformin per day for at least 8 weeks
Subject has HbA1c value of 7.0% and < 11% at screening
Subject is willing to follow AHA weight maintaining diet and exercise program
Subject is a nonsmoker for at least 6 months

Exclusion criteria

Subject has type 1 diabetes
Subject has a history of stroke or chronic seizure
Subject has a history of neoplastic disease
Subject has a history of gastrointestinal, cardiovascular, blood, liver kidney, respiratory, immunological or genitourinary disorders or diseases
Subject is currently taking 2 or more diabetes medications
Subject has glaucoma or is blind
If female, subject is pregnant or breastfeeding
Subject consumes > 3 alcoholic beverages per day
Subject has had major surgery or has donated blood in the last 4 weeks