Evaluation of the Safety and Efficacy of Insulin Glargine 300 U/ml (Gla-300) in Insulin-naïve Pat… (NCT04980027) | Clinical Trial Compass
CompletedPhase 4
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
India228 participantsStarted 2021-06-07
Plain-language 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)
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
What they're measuring
1
Percentage of participants with Treatment Emergent Adverse Events (TEAEs)