Clinical trial NCT01152242: Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin (0000-168)
Official title: A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Keywords: Insulin
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 36
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
timeFrame: Baseline and 30 hours
measure: Part II: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR (AUC of glucose infusion rate), GIRmax (maximum level of glucose infusion rate), over the duration of action of glargine
timeFrame: Baseline and 30 hours
Secondary outcomes:
measure: Part I: The within-subject coefficient of variation in time-action profile of glargine for AUC-GIR and GIRmax over the duration of action of glargine
timeFrame: Baseline and 30 hours
measure: Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action)
timeFrame: Baseline and 30 hours
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References: