Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: Male

Summary

The purpose of this study is to evaluate whether the within-subject variation in duration of action and time-action profile of glargine measured by isoglycemic clamp will be below prespecified levels.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Part 1:

• Patient is a male between 18 to 45 years of age (inclusive) at the prestudy (screening) visit

• Patient has a clinical diagnosis of type 1 diabetes

• Patient must have been treated with insulin since diagnosis and be on a stable dose of insulin

• Patient has a Body Mass Index (BMI) of <=27 kg/m2 and >18 kg/m2

• Patient has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Part 2:

• Subject is a male between 18 to 45 years of age at the prestudy (screening) visit

• Subject has a Body Mass Index (BMI) of <=25 kg/m^2

• Subject has been a nonsmoker and/or has not used nicotine or nicotine-containing products for at least approximately 6 months

Exclusion Criteria:

Part 1:

• Patient has a history of stroke, chronic seizures, or major neurological disorder

• Patient has currently active and untreated clinically significant endocrine, cardiovascular, hematological, hepatic, renal, respiratory, or genitourinary abnormalities or diseases

• Patient has a history of hypertension requiring treatment

• Patient has a history of neoplastic disease within the past 5 years

• Patient is currently being treated with, or has a history of treatment with any oral antihyperglycemic agent

• Patient has a history of significant multiple and/or severe allergies

Part 2:

• Subject has a history of stroke, chronic seizures, or major neurological disorder

• Subject has a history of hypertension requiring treatment

• Subject has a history of neoplastic disease within the past 5 years

• Subject has history of diabetes (Type 1, Type 2 or steroid-induced) or family history of diabetes mellitus

• Subject has a history of hypersensitivity to glargine or any of its inactive ingredients