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
- Registration Number
- NCT04980027
- Lead Sponsor
- Sanofi
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 228
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insuline Glargine (U300) (Gla-300) Insulin glargine (U300) 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
- Primary Outcome Measures
Name Time Method Percentage of participants with Treatment Emergent Adverse Events (TEAEs) Baseline to Week 24 TEAEs including serious adverse events (SAEs) and hypoglycemic episode
- Secondary Outcome Measures
Name Time Method 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 Percentage of participants requiring rescue therapy 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 insulin dose from Baseline to Week 12 and Week 24 Baseline to Week 12 and Week 24 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 Change in 7-point SMBG profile from Baseline to Week 24 Baseline to Week 24 Change in DTSQs scores from Baseline to Week 12 and Week 24 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)
Change in body weight from Baseline to Week 12 and Week 24 Baseline to Week 12 and Week 24
Trial Locations
- Locations (2)
Investigational site Number 3560003
🇮🇳Jaipur, India
Investigational site Number 3560013
🇮🇳Nasik, India