Single Dose Study With a New Insulin Glargine Formulation and Lantus® in Japanese Patients With Type 1 Diabetes Mellitus

Study Overview
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Brief Summary
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Primary Objective: To compare the pharmacodynamic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® Secondary Objective: To compare the pharmacokinetic properties of two different doses of a new insulin glargine formulation with 0.4 U/kg Lantus® To assess the safety and tolerability of a new insulin glargine formulation

Detailed Description
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The study duration per patient will be 4 to 12 weeks including 3 treatment periods each separated by a wash-out period of 6-20 days

Official Title
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A Randomized, Double-blind, 3-sequence, 3-period Cross-over, Single-dose Study of a New Formulation of Insulin Glargine Compared to the Marketed Lantus® in Japanese Patients With Type 1 Diabetes Mellitus Using the Euglycemic Clamp Technique

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin glargine HOE901
* Drug: Insulin glargine - New formulation HOE901


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Japanese male or female subjects, between 20 and 65 years of age, inclusive, with type 1 diabetes mellitus for more than one year, as defined by the Japanese Diabetes Society Body weight between 50.0 kg and 95.0 kg Body Mass Index between 18.0 and 30.0 kg/m2 inclusive Stable insulin regimen for at least 2 months prior to study Certified as otherwise healthy for type 1 diabetes mellitus patient by assessment of medical history and physical examination Women of childbearing potential must have a negative pregnancy test and must use a highly effective method of birth control. During the entire study female subjects of child bearing potential must use two independent methods of contraception. The accepted double contraception methods include use of an intra-uterine device or hormonal contraception in addition to one of the following contraceptive options: 1) condom; 2) diaphragm 3) spermicide. Exclusion criteria: Any history or presence of clinically relevant cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic (apart from diabetes mellitus type 1), hematological, neurological, psychiatric, systemic (affecting the body as a whole), ocular, gynecologic (if female), or infectious disease; any acute infectious disease or signs of acute illness More than one episode of severe hypoglycemia with seizure, coma or requiring assistance of another person during the past 6 months Presence or history of a drug allergy or clinically significant allergic disease according to the Investigator's judgment Participation in a trial with any investigational drug during the past 4 months Symptoms of a clinically significant illness in the 3 months before the study, which, according to the investigator's opinion, could interfere with the purposes of the study Regular use of any medication other than insulins in the last month before study start with the exception of thyroid hormones, lipid-lowering and antihypertensive drugs, and, if female, with the exception of hormonal contraception or menopausal hormone replacement therapy; any vaccination within the last 28 days Known hypersensitivity to insulin glargine or excipients of the study drug Any history or presence of deep leg vein thrombosis or a frequent appearance of deep leg vein thrombosis in first degree relatives (parents, siblings or children) The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

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: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) | Drug: Insulin glargine HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>* Other names: Lantus®;Drug: Insulin glargine - New formulation HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|
| Experimental: Sequence 2<br>Test1 (insulin glargine - new formulation dose 1) - Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) | Drug: Insulin glargine HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>* Other names: Lantus®;Drug: Insulin glargine - New formulation HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|
| Experimental: Sequence 3<br>Test2 (insulin glargine - new formulation dose 2) - Reference (insulin glargine) - Test1 (insulin glargine - new formulation dose 1) | Drug: Insulin glargine HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>* Other names: Lantus®;Drug: Insulin glargine - New formulation HOE901<br>* Pharmaceutical form:solution for injection Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose infusion rate |  | up to day 2 of each period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameter : Cmax |  | up to day 2 of each period | 
| Pharmacokinetic parameter : Tmax |  | up to day 2 of each period | 
| Pharmacokinetic parameter : AUC |  | up to day 2 of each period | 
| Number of patients with adverse events |  | up to day 3 of each period | 
| Safety-related parameters including electrocardiogram, vital signs and laboratory tests |  | up to day 3 of each period |