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

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin Glargine

Criteria

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.