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An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00511472
Recruitment Status : Completed
First Posted : August 6, 2007
Results First Posted : July 11, 2012
Last Update Posted : July 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
A study to assess safety, pharmacokinetics (PK), and pharmacodynamics (PD) of MK-0941 in Type 2 diabetics being treated with basal insulin.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: MK-0941 Drug: Placebo Drug: LANTUS insulin Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-0941 on Postprandial Plasma Glucose Concentrations After Daily Administration MK-0941 Before Each Meal (q.a.c) in Subjects With Type 2 Diabetes Being Treated With Basal Insulin
Study Start Date : July 2007
Primary Completion Date : April 2008
Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: MK-0941 Drug: MK-0941

In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis (Titration Dose [TD] Days 1 to 4 of the Titration Phase 1) in 10-mg q.a.c. increments.

Titration Scheme #2 was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration on Days 1 to 4 of the Titration Phase 2.

Drug: LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Other Name: LANTUS
Placebo Comparator: Placebo Drug: Placebo
10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
Drug: LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin
Other Name: LANTUS


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event During the Study [ Time Frame: 39 days ]

Secondary Outcome Measures :
  1. Number of Participants Who Experienced an Adverse Event - Titration Scheme 1 [ Time Frame: 25 days ]
    In Titration Scheme #1, MK-0941/matching placebo was initiated at 10-mg q.a.c. dose and increased on a daily basis in 10-mg q.a.c. increments on Titration Dose [TD] Days 1 to 4 of the Titration Phase 1 of the study.

  2. Number of Participants Who Experienced an Adverse Event - Titration Scheme 2 [ Time Frame: 25 days ]
    Titration Scheme #2 (Titration Phase, Days 1 to 4) was a flexible-dose titration scheme in which MK-0941/matching placebo was given at a dose determined by a pre-prandial plasma glucose concentration for the subsequent meal on the previous day of administration.

  3. 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 [ Time Frame: 24 hours ]
    Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.

  4. Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period [ Time Frame: Outpatient Days 1 to 14 ]
    During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female (of non-childbearing potential) between 18 to 70 years of age
  • Diagnosed with Type 2 Diabetes and currently being treated with basal insulin
  • Smokers may participate, but they are limited to 10 cigarettes per day while at the clinic and must follow clinic smoking rules

Exclusion Criteria:

  • History of Type 1 diabetes
  • Treated with peroxisome proliferator-activated receptor (PPAR) agonists within 12 weeks prior to study start
  • History of severe hypoglycemia
  • Allergic to insulin
Contacts and Locations

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): NCT00511472


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00511472     History of Changes
Other Study ID Numbers: 0941-006
2007_596
MK-0941-006
First Posted: August 6, 2007    Key Record Dates
Results First Posted: July 11, 2012
Last Update Posted: July 15, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs