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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00873821
• Other study ID #: 0941-012
• Secondary ID: 2008_533
• Status: Completed
• Phase: Phase 1
• First received: March 31, 2009
• Last updated: February 24, 2015
• Start date: December 2008
• Est. completion date: May 2009

Study information

• Verified date: February 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Any Clinical Adverse Experience	An adverse experience was defined as any unfavorable and unintended change in the structure or function of the body temporally associated with the use of study drug. Adverse experiences were collected using Medical Dictionary for Regulatory Activities (MedDRA) version 13.0.	2 months	Yes
Primary	Number of Participants With Any Laboratory Adverse Experience	Laboratory adverse experiences were those related to changes in hematology, fasted blood chemistry, or urinalysis laboratory results. Adverse experiences were collected using MedDRA version 13.0.	2 months	Yes
Primary	Change From Baseline to Day 13 in Weighted Mean Plasma Glucose Concentration	Weighted mean plasma glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24	Baseline (predose Day 1) to Day 13	No