Repeated Dose Study With a New Insulin Glargine Formulation and Lantus® on 24-hour Glucose Profile 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 24-hour glycemic profile in continuous glucose monitoring (CGM) between a new formulation of insulin glargine and Lantus at steady state Secondary Objectives: To compare the change of Fasting plasma glucose (FPG), Self-monitoring plasma glucose (SMPG) and Postprandial Plasma Glucose (PPG) between the 2 treatments; To compare the efficacy of the 2 treatments on glycemic control in glycemic parameters (1,5-anhydroglucitol and hemoglobin A1c (glycosylated hemoglobin; HbA1c)); To compare the occurrence of hypoglycemia between the 2 treatments; To assess the safety and tolerability of a new formulation of insulin glargine.

Detailed Description
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66 days

Official Title
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A Randomized, Open-label, 2-treatment Crossover Study of a New Formulation of Insulin Glargine Comparing to Lantus® on 24-hour Glucose Profile in Japanese Patients With Type 1 Diabetes Mellitus on Treatment With Basal-bolus Insulin

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 patients with Type 1 Diabetes Mellitus (T1DM) on treatment with basal-bolus insulin; Exclusion criteria: Age < 20 years at written informed consent; HbA1c < 6.5% or > 10.0% at screening Diabetes mellitus (DM) other than T1DM; Body Mass Index (BMI) > 35.0 kg/m2 at screening visit Any contraindication to use of insulin glargine as defined in the Japanese Package Insert Hypoglycemia unawareness or history of metabolic acidosis, including hospitalization for diabetic ketoacidosis during the 24 weeks prior to screening visit 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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence 1<br>Reference (insulin glargine) -Test1 (insulin glargine - new formulation), both dose will be adjusted individually to achieve the target glycemic goal | Drug: insulin glargine (HOE901)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>Drug: insulin glargine- new formulation (HOE901)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|
| Experimental: Sequence 2<br>Test1 - Reference , both dose will be adjusted individually to achieve the target glycemic goal | Drug: insulin glargine (HOE901)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>Drug: insulin glargine- new formulation (HOE901)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 24-hour blood glucose profile measured by continuous glucose monitoring |  | Baseline, Day 28, Day 56 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemia categorized by the definition of American Diabetes Association |  | Up to Day 56 | 
| Change in fasting plasma glucose from baseline to each treatment end by treatment |  | Baseline, Day 28, Day 56 | 
| Change in self monitoring plasma glucose profile from baseline to each treatment end by treatment |  | Baseline, Day 28, Day 56 | 
| Change in HbA1c from baseline to each treatment end by treatment |  | Baseline, Day 28, Day 56 |