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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00511472
• Other study ID #: 0941-006
• Secondary ID: 2007_596MK-0941-
• Status: Completed
• Phase: Phase 1
• First received: August 2, 2007
• Last updated: June 19, 2015
• Start date: July 2007
• Est. completion date: April 2008

Study information

• Verified date: June 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

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.
• Placebo
10 mg Placebo (Pbo), 20 mg Pbo, 30 mg Pbo or 40 mg Pbo q.a.c.
• LANTUS insulin
LANTUS insulin dose will be similar to participant's previous dose of immediate or long-acting insulin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants Who Experienced an Adverse Event During the Study		39 days	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	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	Yes