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

NCT ID: NCT00873821

Last Updated: 2015-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-12-31
• Study Completion Date: 2009-05-31

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

1

MK-0941

Group Type: EXPERIMENTAL

MK-0941

Intervention Type: DRUG

Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.

2

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type: DRUG

Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.

Interventions

MK-0941

Part 1 (in house): MK-0941 twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. The starting dose on Day 1 was 10 mg tablets twice daily and titrated to a maximum dose of 60 mg twice daily through Day 9. The Day 9 dose was maintained throughout Day 13. Part 2 (at home): participants continued treatment for an additional 14 days with MK-0941 60 mg tablets (or maximum dose achieved in Part 1) twice daily, before meals with 240 mL of water.

Intervention Type: DRUG

Comparator: Placebo

Part 1 (in house): placebo twice daily on Days 1 through 13 before breakfast and dinner with 240 mL water. Part 2 (at home): participants continued treatment for an additional 14 days with placebo twice daily, before meals with 240 mL of water.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

2008_533

Identifier Type: -

Identifier Source: secondary_id

0941-012

Identifier Type: -

Identifier Source: org_study_id