A Study to Test MK-0941 in Adults With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0941-018)

NCT ID: NCT00824616

Last Updated: 2015-07-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to test the effect MK-0941 as add-on therapy for adults taking insulin for Type 2 Diabetes.

Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Participants receiving placebo tablets three times daily plus insulin injection once daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablets, taken 3 times daily.

Insulin

Intervention Type DRUG

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

MK-0941

Participants receiving MK-0941 tablets three times daily plus insulin injection once daily

Group Type EXPERIMENTAL

MK-0941

Intervention Type DRUG

MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

Insulin

Intervention Type DRUG

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Interventions

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MK-0941

MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

Intervention Type DRUG

Placebo

Placebo tablets, taken 3 times daily.

Intervention Type DRUG

Insulin

Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.

Intervention Type DRUG

Other Intervention Names

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LANTUS®

Eligibility Criteria

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Inclusion Criteria

* Participant has Type 2 Diabetes Mellitus

Exclusion Criteria

* Participant has a history of Type 1 Diabetes Mellitus or ketoacidosis
* Participant is on a weight loss program and is not in the maintenance phase or is taking a weight loss medication
* Participant has had surgery within 30 days of starting the study or has planned major surgery
Minimum Eligible Age

21 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Other Identifiers

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2009_516

Identifier Type: OTHER

Identifier Source: secondary_id

MK-0941-018

Identifier Type: OTHER

Identifier Source: secondary_id

0941-018

Identifier Type: -

Identifier Source: org_study_id

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