Status:
COMPLETED
Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Diabetes
Eligibility:
MALE
18-45 years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01152242
Start Date
August 1 2010
End Date
May 1 2012
Last Update
July 23 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.