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

Primary Purpose

Type 2 Diabetes Mellitus

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

MK0941

Comparator: Placebo

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MK0941

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Participants With Any Clinical Adverse Experience

Participants Discontinued Because of Any Clinical Adverse Experience

Secondary Outcome Measures

Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941

Maximum Concentration (Cmax) of MK-0941 After Multiple Doses of MK-0941

Time to Maximum Concentration (Tmax) of MK-0941 After Multiple Doses of MK-0941

Apparent Terminal Elimination Half-life (T1/2) of MK-0941 After Multiple Doses of MK0941

Concentration of MK-0941 at 24 Hours (C24hr) After Multiple Doses of MK-0941

Full Information

NCT ID

NCT00511667

First Posted

August 2, 2007

Last Updated

August 23, 2016

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00511667

Brief Title

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

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

May 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MK0941

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

MK0941

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Comparator: Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Participants With Any Clinical Adverse Experience

Time Frame

Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Title

Participants Discontinued Because of Any Clinical Adverse Experience

Time Frame

Approximately 30 days after last dose of study drug (14 days for participants receiving MK0941 40 mg before each meal)

Secondary Outcome Measure Information:

Title

Area Under the Concentration-time Curve (AUC0-24) of MK-0941 After Multiple Doses of MK0941

Time Frame