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An Investigational Drug Study in Adults With Type 2 Diabetes on Basal Insulin (MK-0941-006 AM3)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT00511472
First received: August 2, 2007
Last updated: July 24, 2012
Last verified: July 2012
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants Who Experienced an Adverse Event During the Study [ Time Frame: 39 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of Participants Who Experienced an Adverse Event - Titration Scheme 1 [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]
    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.

  • Number of Participants Who Experienced an Adverse Event - Titration Scheme 2 [ Time Frame: 25 days ] [ Designated as safety issue: Yes ]
    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.

  • 24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.

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


Enrollment: 70
Study Start Date: July 2007
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00511472

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT00511472     History of Changes
Other Study ID Numbers: MK-0941-006, 2007_596
Study First Received: August 2, 2007
Results First Received: April 10, 2012
Last Updated: July 24, 2012
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 16, 2013