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 (SAFEGUARD)

Study Overview

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)

Study details

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.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Type 2 Diabetes Mellitus
  • Age: 18 Years
  • Gender: All

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.

Updated on 31 Jan 2023. Study ID: NCT04980027