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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: MK-0941; Drug: Placebo; Drug: LANTUS insulin

• Registration Number: NCT00511472
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-08-02
• Study First Submitted QC: 2007-08-03
• Study First Posted: 2007-08-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2012-04-10
• Results First Submitted QC: 2012-06-06
• Results First Posted: 2012-07-11
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-19
• Last Update Posted: 2015-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MK-0941	LANTUS insulin	-
MK-0941	MK-0941	-
Placebo	Placebo	-
Placebo	LANTUS insulin	-

Primary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced an Adverse Event During the Study	39 days

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experienced an Adverse Event - Titration Scheme 1	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.
Number of Participants Who Experienced an Adverse Event - Titration Scheme 2	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.
24-Hour Weighted Mean Blood Glucose Levels (mg/dL) by Treatment Group on Day 7	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.
Number of Participants Who Experienced an Adverse Event During the Outpatient Treatment Period	Outpatient Days 1 to 14	During the Outpatient Treatment Period, participants were followed for an additional 2 weeks while at home.