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

Merck Sharp & Dohme LLC70 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Type 2 Diabetes Mellitus

Interventions

MK-0941DRUG

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.

PlaceboDRUG

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

LANTUS insulinDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of Participants Who Experienced an Adverse Event During the Study

Time frame: 39 days

Secondary Outcomes

Number of Participants Who Experienced an Adverse Event - Titration Scheme 1

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.

Time frame: 25 days

Number of Participants Who Experienced an Adverse Event - Titration Scheme 2

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.

Time frame: 25 days

24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7

Measurement of the 24-hour weighted mean blood glucose levels of participants receiving MK-0941 or placebo while on basal insulin on Day 7.

Time frame: 24 hours

Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period

During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.

Time frame: Outpatient Days 1 to 14

Data from ClinicalTrials.gov

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