Clinical trial NCT00511667: A Multiple Dose Investigational Drug Study in Patients With Type 2 Diabetes (MK-0941-005)
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2007-08-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participants With Any Clinical Adverse Experience
timeFrame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
measure: Participants Discontinued Because of Any Clinical Adverse Experience
timeFrame: Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)
Secondary outcomes:
measure: Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941
timeFrame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
measure: Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941
timeFrame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
measure: Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941
timeFrame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
measure: Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941
timeFrame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
measure: Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941
timeFrame: Up to 72 hours after dosing (up to 24 hours for participants receiving MK0941 60 mg before 2 meals each day)
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: