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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00511472
First received: August 2, 2007
Last updated: May 29, 2014
Last verified: May 2014
  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:


Further study details as provided by Merck Sharp & Dohme Corp.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00511472

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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00511472     History of Changes
Other Study ID Numbers: 0941-006, 2007_596, MK-0941-006
Study First Received: August 2, 2007
Results First Received: April 10, 2012
Last Updated: May 29, 2014
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 July 20, 2014