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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: MK-0941; Drug: LANTUS insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00511472

0941-006

2007_596

MK-0941-006

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups, including a placebo group

MK-0941

Experimental group

Treatment:

Drug: LANTUS insulin

Drug: MK-0941

Placebo

Placebo Comparator group

Treatment:

Drug: LANTUS insulin

Drug: Placebo