Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Patients With Type 2 Diabetes Mellitus Uncontrolled on Oral Antihyperglycemic Drugs

Study Overview
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Brief Summary
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Primary Objective: To evaluate the safety of Gla-300 in insulin naïve T2D participants uncontrolled on oral antihyperglycemic drugs Secondary Objective: To assess the efficacy of Gla-300 on glycemic control in insulin naïve T2D participants uncontrolled on oral anti-hyperglycemic drugs To assess change in participant's treatment satisfaction using DTSQs (Diabetes Treatment Satisfaction Questionnaire)

Detailed Description
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The maximum study duration per participant is 27 weeks including a screening period of up to 2 weeks, a 24-week treatment period and a post-treatment follow-up phone call visit after 3 days after the end of treatment.

Official Title
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Multicentre Phase IV Single Arm Clinical Trial to evaluAte the saFety and Efficacy of Gla-300 in insUlin-naïve Patients With Type 2 DiAbetes uncontRolled on Oral Antihyperglycemic Drugs

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 who are insulin naïve on at least one oral antihyperglycemic drug (metformin,sulfonylurea, thiazolidinedione, DPP-4 inhibitor, SGLT-2 inhibitor, glinide, α-glucosidase inhibitor) with or without glucagon-like peptide 1 receptor agonists (GLP-1 RAs) for a minimum period of 6 months prior to screening. HbA1c between 7.5% (58 mmol/mol) and 10% (86 mmol/mol) inclusive, during screening. Exclusion criteria: History of severe hypoglycemia requiring emergency room admission or hospitalization within 3 months prior to screening visit. Proliferative retinopathy or maculopathy requiring treatment according to the Investigator Treatment with any insulin including basal insulin, mixed insulin (premixes), rapid insulin, and 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). Use of systemic glucocorticoids (excluding topical application or inhaled forms) for 2 weeks or more within 8 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: 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: Insuline Glargine (U300) (Gla-300)<br>Insulin glargine (U300) once daily for 24 weeks on top of non-insulin antidiabetic drug. Insulin dose will be adjusted according to the recommended titration algorithm | Drug: Insulin glargine (U300)<br>* Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous<br>* Other names: HOE901 Toujeo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with Treatment Emergent Adverse Events (TEAEs) | TEAEs including serious adverse events (SAEs) and hypoglycemic episode | Baseline to Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participants with at least one confirmed hypoglycemia event |  | Baseline to Week 24 | 
| Change in HbA1c from Baseline to week 12 and week 24 |  | Baseline to Week 12 and Week 24 | 
| Percentage of participants reaching HbA1c target of <7% |  | Week 12 and Week 24 | 
| Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L) |  | Week 12 and Week 24 | 
| Change in fasting plasma glucose (FPG) from Baseline to Week 24 |  | Baseline to Week 24 | 
| Change in fasting SMBG from Baseline to Week 24 |  | Baseline to Week 24 | 
| Change in 7-point SMBG profile from Baseline to Week 24 |  | Baseline to Week 24 | 
| Percentage of participants requiring rescue therapy |  | Week 12 and Week 24 | 
| Change in body weight from Baseline to Week 12 and Week 24 |  | Baseline to Week 12 and Week 24 | 
| Change in insulin dose from Baseline to Week 12 and Week 24 |  | Baseline to Week 12 and Week 24 | 
| Change in DTSQs scores from Baseline to Week 12 and Week 24 | The Diabetes Treatment Satisfaction Questionnaire - status version (DTSQs) is measuring patients' satisfaction with their diabetes treatment.Total treatment satisfaction score range from 0 (no satisfaction) to 36 (improvement in treatment satisfaction) | Baseline to Week 12 and Week 24 |