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

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ClinicalTrials.gov Identifier: NCT00824616
Recruitment Status : Completed
First Posted : January 19, 2009
Results First Posted : August 21, 2012
Last Update Posted : July 28, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MK-0941 Drug: Placebo Drug: Insulin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: LANTUS®
Experimental: MK-0941
Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
 Drug: MK-0941
MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.

Drug: Insulin
Insulin glargine (rDNA origin) injection solution for subcutaneous (SC) injection, taken once daily.
Other Name: LANTUS®


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824616


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
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Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information
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Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00824616    
Other Study ID Numbers: 0941-018
2009_516 ( Other Identifier: Merck Registration ID )
MK-0941-018 ( Other Identifier: Merck Protocol ID )
First Posted: January 19, 2009    Key Record Dates
Results First Posted: August 21, 2012
Last Update Posted: July 28, 2015
Last Verified: July 2015
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs