A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Sequential Panel Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK0941 After Multiple Daily Administration of MK0941 Before Each Meal (q.a.c.) in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511667
• Other study ID #: 0941-005
• Secondary ID: 2007_595
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2007
• Last updated: August 23, 2016
• Start date: May 2007
• Est. completion date: April 2008

Study information

• Verified date: August 2016
• 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 multiple dose study to assess the safety and pharmacokinetics of an investigational drug in patients with type 2 diabetes. The primary hypotheses of the study are that multiple daily MK-0941 in subjects with T2DM with or without adequate control on metformin will be sufficiently safe and well tolerated to permit continued clinical investigation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Nonsmoking Male or Female (of non-child bearing potential)

• Diagnosis of Type 2 Diabetes and is being treated with diet and exercise alone or with less than 3 oral anti-hyperglycemic agents

• Panel E only (MK0941 60 mg before 2 meals each day): diagnosis of Type 2 Diabetes and is on a dose of metformin of greater than or equal to 1500 mg for 8 weeks or more

Exclusion Criteria:

• Subject is on insulin or a peroxisome proliferator-activated receptor (PPAR) agonist

• Subject is on 3 or more oral anti-diabetes medications

• Subject has a history of type 1 diabetes

• Subject has a diagnosis of glaucoma or is blind

• Subject has had trauma to one or both eyes

Study Design

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• MK0941
MK0941 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day
• Comparator: Placebo
Placebo 10 mg, 20 mg, 30 mg, or 40 mg before each meal or before 2 meals each day, or 60 mg before 2 meals each day

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	Participants With Any Clinical Adverse Experience		Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)	Yes
Primary	Participants Discontinued Because of Any Clinical Adverse Experience		Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)	Yes
Secondary	Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941		Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)	No
Secondary	Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941		Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)	No
Secondary	Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941		Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)	No
Secondary	Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941		Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)	No
Secondary	Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941		Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)	No