Comparison of the Efficacy and Safety of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Insufficiently Controlled With Non-insulin Antidiabetic Therapy

Study Overview
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Brief Summary
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Primary Objective: To compare the efficacy of insulin glargine (U300) and Lantus in terms of change of glycated hemoglobin A1c (HbA1c) from baseline to endpoint (scheduled at Month 6, Week 26) in patients with type 2 diabetes mellitus. Secondary Objectives: To compare insulin glargine (U300) and Lantus in terms of occurrence of hypoglycemia and nocturnal hypoglycemia. To compare insulin glargine (U300) and Lantus in terms of reaching target HbA1c values (all and reaching target without hypoglycemia). To compare insulin glargine (U300) and Lantus in terms of controlled plasma glucose (all and reaching target without hypoglycemia). To compare the frequency of occurrence and diurnal distribution of hypoglycemia by category of hypoglycemia (documented symptomatic, asymptomatic, nocturnal, severe, probable and relative). To assess the safety and tolerability of insulin glargine (U300). To assess the development of anti-insulin glargine antibodies (AIA).

Detailed Description
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The total maximum study duration per patient will be 29 weeks that will consist of a 2-week screening period, 26-week treatment period, and a 2-day post-treatment safety follow-up period.

Official Title
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6-Month, Multicenter, Randomized, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With Non-Insulin Antihyperglycemic Drugs

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: Insulin glargine (U300)
* Drug: Insulin glargine
* Drug: Non-insulin antihyperglycemic drugs


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Adult patients with type 2 diabetes mellitus inadequately controlled with non-insulin antihyperglycemic drug(s). Signed written informed consent. Exclusion criteria: Age < legal age of adulthood. HbA1c <7.0% (<53 mmol/mol) or >11% (>97 mmol/mol) (at screening). History of type 2 diabetes mellitus for less than 1 year before screening. Less than 6 months before screening with non-insulin antihyperglycemic treatment. Change in dose of non-insulin antihyperglycemic treatment in the last 3 month before screening. Initiation of new glucose-lowering medications and/or weight loss drug in the last 3 months before screening visit and/or initiation of glucagon like peptide-1(GLP-1) receptor agonist in the last 6 months before screening visit. Patients receiving only non-insulin antihyperglycemic drugs not approved for combination with insulin according to local labeling (Note: non-insulin antihyperglycemic drugs not approved for combination with insulin are to be discontinued at randomization). Current or previous insulin use except for a maximum of 10 consecutive days (eg, acute illness, surgery) during the last one year prior to screening. Severe hypoglycemia resulting in coma/seizures, and/or hospitalization for diabetic ketoacidosis in the last 6 months before screening visit. Unstable proliferative diabetic retinopathy or any other rapidly progressive diabetic retinopathy or macular edema likely to require treatment (eg, laser, surgical treatment or injectable drugs) during the study period. 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: 18 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Toujeo - insulin glargine (U300)<br>Toujeo - Insulin glargine (U300) will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks | Drug: Insulin glargine (U300)<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901; Toujeo;Drug: Non-insulin antihyperglycemic drugs<br>* Pharmaceutical form: capsule/tablet Route of administration: oral<br>* Other names: Non-insulin antihyperglycemic therapy;|
| Active Comparator: Lantus - insulin glargine<br>Lantus - Insulin glargine will be administered subcutaneously once in the evening on top of the non-insulin antihyperglycemic drugs for 29 weeks | Drug: Insulin glargine<br>* Pharmaceutical form: solution Route of administration: subcutaneous<br>* Other names: HOE901; Lantus;Drug: Non-insulin antihyperglycemic drugs<br>* Pharmaceutical form: capsule/tablet Route of administration: oral<br>* Other names: Non-insulin antihyperglycemic therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c from baseline |  | Baseline, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage (%) of patients with at least one hypoglycemia |  | Baseline, up to 6 months | 
| Percentage (%) of patients with at least one nocturnal hypoglycemia |  | Baseline, up to 6 months | 
| Percentage (%) of patients with HbA1c <7.0% |  | 6 months | 
| Percentage (%) of patients with HbA1c ≤6.5% |  | 6 months | 
| Percentage (%) of patients with Fasting Plasma Glucose (FPG) <100 mg/dL (5.6 mmol/L) |  | 6 months | 
| Percentage (%) of patients with FPG ≤120 mg/dL (6.7 mmol/L) |  | 6 months | 
| Percentage (%) of patients requiring rescue therapy |  | 6 months | 
| Change in fasting plasma glucose |  | Baseline, 6 months | 
| Change in 8-point Self-monitored Plasma Glucose (SMPG) profiles |  | Baseline, 6 months | 
| Change of mean 24-hour plasma glucose |  | Baseline, 6 months | 
| Change in variability of plasma glucose profile |  | Baseline, 6 months | 
| Change in daily basal insulin dose |  | Baseline, 6 months |