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

July 21, 2015 updated by: Merck Sharp & Dohme LLC

A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of MK-0941 in Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Participants receiving placebo tablets three times daily plus insulin injection once daily
Drug: Placebo
Placebo tablets, taken 3 times daily.
Drug: Insulin
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Other Names:
  • LANTUS®
Experimental: MK-0941
Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
Drug: Insulin
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Other Names:
  • LANTUS®
Drug: MK-0941
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Hemoglobin A1c (HbA1c) Level
Time Frame: Baseline (Day 1) and End of Treatment (Week 20)
HbA1c level is a blood test measurement of the amount (percent) of hemoglobin that is glycated (or has glucose on it). HbA1c level is related to the average blood glucose concentration over the previous 2-3 months, with a higher HbA1c level indicating a higher amount of average plasma glucose. A negative number for change from baseline in HbA1c level means a reduction in HbA1c level and indicates better control of average plasma glucose levels.
Baseline (Day 1) and End of Treatment (Week 20)
Number of Participants Who Experienced One or More Episodes of Hypoglycemia (Symptomatic or Asymptomatic)
Time Frame: From first dose of study drug (Week 0) to last dose of study drug (Week 20)
Hypoglycemic episodes - with or without symptoms - are defined as a fingerstick glucose measurement of ≤70 mg/dL (3.9 mmol/L). Excludes data after initiation of glycemic rescue therapy.
From first dose of study drug (Week 0) to last dose of study drug (Week 20)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0941-018
  • 2009_516 (Other Identifier: Merck Registration ID)
  • MK-0941-018 (Other Identifier: Merck Protocol ID)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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