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Completed

NCT Number: NCT00511472

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

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

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MK-0941

Drug

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.

Placebo

Drug

10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.

LANTUS insulin

Drug

LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin

Other names: LANTUS

Primary outcomes

  1. Number of Participants Who Experienced an Adverse Event During the Study

    Time frame: 39 days

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Aug 6, 2007
Registry last updated
Jul 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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