Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin

Study Overview
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Brief Summary
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Primary Objective: To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300. Secondary Objectives: To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes. To evaluate the safety of Gla-300.

Detailed Description
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Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.

Official Title
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A Multicenter, Multinational, Prospective, Interventional, Single-arm, Phase IV Study Evaluating the Clinical Efficacy and Safety of 26 Weeks of Treatment With Insulin Glargine 300 U/mL (Gla-300) in Patients With Type 2 Diabetes Mellitus Uncontrolled on Basal Insulin

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: INSULIN GLARGINE (U300)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria : Participants with type 2 diabetes mellitus. Participants on standard of care basal insulin therapy administered once or twice daily, as per labeling for at least 6 months prior to screening visit, with or without other antidiabetics approved for using with insulin. Glycated hemoglobin (HbA1c) between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. Fasting plasma glucose values above 130 mg/dL. Exclusion criteria: Unstable basal insulin regimen in the last 8 weeks prior to screening visit (ie, type of insulin and time/frequency of the injection, insulin doses [variation more than ±20%]). Treatment with insulin other than basal insulin: mixed insulin (premixes), rapid insulin, fast acting insulin analogues in the last 6 months before screening visit (use ≤10 days in relation to hospitalization or an acute illness is accepted). 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin glargine (U300)<br>Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin | Drug: INSULIN GLARGINE (U300)<br>* Pharmaceutical form: Solution for injection in a prefilled pen Route of administration: Subcutaneous<br>* Other names: HOE901, Toujeo, Gla-300;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated hemoglobin (HbA1c) | Absolute change in HbA1c | Baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycated hemoglobin (HbA1c) | Absolute change in HbA1c | Baseline to Week 12 | 
| Participants with HbA1c below 7% | Percentage of participants with HbA1c below 7% | Week 12 and 26 | 
| Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) | Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) | Week 12 and 26 | 
| Change in fasting SMPG | Absolute change in fasting SMPG | Baseline to Week 26 | 
| Change in SMPG profile | Absolute change in SMPG profile | Baseline to Week 26 | 
| Change in fasting plasma glucose (FPG) | Absolute change in FPG | Baseline to Week 26 | 
| Percentage of participants requiring rescue therapy | Percentage of participants requiring rescue therapy by additional antidiabetic medication | Baseline to Week 12 and 26 | 
| Number of participants with hypoglycemia events | Number of participants with at least 1 hypoglycemia event | Baseline to Week 26 | 
| Number of participants with adverse events (AEs) | Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness). | Baseline to Week 27 | 
| Change in Treatment satisfaction | Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire | Baseline to Week 26 | 
| Number of participants with health care utilization | Number of participants with health care utilization, including hospitalization, emergency room visits, and office [or specialty] visits | Baseline to Week 26 |