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

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

Official Title
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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

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: MK-0941
* Drug: Placebo
* Drug: LANTUS insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MK-0941<br> | Drug: MK-0941<br>* 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.<br>Drug: LANTUS insulin<br>* LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin<br>* Other names: LANTUS;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.<br>Drug: LANTUS insulin<br>* LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin<br>* Other names: LANTUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced an Adverse Event During the Study |  | 39 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | Outpatient Days 1 to 14 |