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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00824616
First received: January 16, 2009
Last updated: July 17, 2012
Last verified: July 2012
History of Changes

January 16, 2009
July 17, 2012
January 2009
May 2010   (final data collection date for primary outcome measure)
  • Change From Baseline in Hemoglobin A1c (HbA1c) Level [ Time Frame: Baseline (Day 1) and End of Treatment (Week 20) ] [ Designated as safety issue: No ]
    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.
  • 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) ] [ Designated as safety issue: Yes ]
    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.
Assess the effect of treatment with MK0941 compared with placebo on A1C when added to insulin [ Time Frame: 20 Weeks ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00824616 on ClinicalTrials.gov Archive Site
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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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: MK-0941
    MK-0941 tablets 5 mg or 10 mg, taken 3 times daily, with increasing doses to maximally effective dose.
  • 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®
  • Placebo Comparator: Placebo
    Participants receiving placebo tablets three times daily plus insulin injection once daily
    Interventions:
    • Drug: Placebo
    • Drug: Insulin
  • Experimental: MK-0941
    Participants receiving MK-0941 tablets three times daily plus insulin injection once daily
    Interventions:
    • Drug: MK-0941
    • Drug: Insulin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
68
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
21 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00824616
0941-018, 2009_516, MK-0941-018
Not Provided
Merck
Merck
Not Provided
Study Director: Medical Monitor Merck
Merck
July 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP