Clinical trial NCT04980027: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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)

Detailed description: 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: 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.

Primary outcomes:
measure: Percentage of participants with Treatment Emergent Adverse Events (TEAEs)
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: Percentage of participants with at least one confirmed hypoglycemia event
timeFrame: Baseline to Week 24
measure: Change in HbA1c from Baseline to week 12 and week 24
timeFrame: Baseline to Week 12 and Week 24
measure: Percentage of participants reaching HbA1c target of <7%
timeFrame: Week 12 and Week 24
measure: Percentage of participants reaching targeted fasting self-monitored blood glucose (SMBG) of 80 to 110 mg/dL (4.4 to 6.1 mmol/L)
timeFrame: Week 12 and Week 24
measure: Change in fasting plasma glucose (FPG) from Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in fasting SMBG from Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Change in 7-point SMBG profile from Baseline to Week 24
timeFrame: Baseline to Week 24
measure: Percentage of participants requiring rescue therapy
timeFrame: Week 12 and Week 24
measure: Change in body weight from Baseline to Week 12 and Week 24
timeFrame: Baseline to Week 12 and Week 24
measure: Change in insulin dose from Baseline to Week 12 and Week 24
timeFrame: Baseline to Week 12 and Week 24
measure: Change in DTSQs scores from Baseline to Week 12 and Week 24
timeFrame: Baseline to Week 12 and Week 24
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Investigational site Number 3560003
city: Nasik
country: India
facility: Investigational site Number 3560013
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: