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

Study Overview
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Brief Summary
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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.

Official Title
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A Two-Part Clinical Trial to Assess Pharmacodynamic and Pharmacokinetic Variability of a Basal Insulin

Conditions
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Diabetes

Intervention / Treatment
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* Drug: Isoglycemic Clamp
* Drug: Comparator: insulin glargine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part 1<br>Part I of the trial | Drug: Isoglycemic Clamp<br>* Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)<br>Drug: Comparator: insulin glargine<br>* Insulin glargine at 0.4 U/kg<br>* Other names: LANTUS;|
| Active Comparator: Part 2<br>Part II of the trial | Drug: Isoglycemic Clamp<br>* Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)<br>Drug: Comparator: insulin glargine<br>* Insulin glargine at 0.4 U/kg<br>* Other names: LANTUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part I: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) |  | Baseline and 30 hours | 
| 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 |  | Baseline and 30 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Baseline and 30 hours | 
| Part II: The within-subject standard deviation in duration of action of glargine (the difference between onset of action and end of action) |  | Baseline and 30 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin