Evaluation of the Efficacy and Safety of Insulin Glargine 300 U/mL in Patients With Type 2 Diabetes Mellitus Uncontrolled on Other Kinds of Insulin
- Registration Number
- NCT03760991
- Lead Sponsor
- Sanofi
- Brief Summary
Primary Objective:
To assess the efficacy of Gla-300 on glycemic control measured by hemoglobin A1c (HbA1c) change in patients with type 2 diabetes mellitus (T2DM) uncontrolled with their current basal insulin following the switch to Gla-300.
Secondary Objectives:
To evaluate the effects of Gla-300 on glycemic control, treatment satisfaction, and health care resource utilization (HCRU) outcomes.
To evaluate the safety of Gla-300.
- Detailed Description
Study duration per participant is approximately 29 weeks including a screening period of up to 2 weeks, a 26-week treatment period, and a post treatment follow-up phone call visit at Week 27.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 372
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Insulin glargine (U300) INSULIN GLARGINE (U300) Insulin glargine (U300) (Gla-300) once daily for 26 weeks on top of any other antidiabetic treatment except other basal insulin
- Primary Outcome Measures
Name Time Method Change in glycated hemoglobin (HbA1c) Baseline to Week 26 Absolute change in HbA1c
- Secondary Outcome Measures
Name Time Method Participants with fasting self-monitored plasma glucose (SMPG) of 80 to 110 mg/dL (4.4 to 7.2 mmol/L) Week 12 and 26 Percentage of participants reaching targeted fasting SMPG of 80 to 110 mg/dL (4.4 to 7.2 mmol/L)
Number of participants with adverse events (AEs) Baseline to Week 27 Number of participants with AEs, serious adverse events (SAEs) (including hypoglycemic episodes associated with seizures, coma, or unconsciousness).
Percentage of participants requiring rescue therapy Baseline to Week 12 and 26 Percentage of participants requiring rescue therapy by additional antidiabetic medication
Change in glycated hemoglobin (HbA1c) Baseline to Week 12 Absolute change in HbA1c
Change in SMPG profile Baseline to Week 26 Absolute change in SMPG profile
Change in fasting plasma glucose (FPG) Baseline to Week 26 Absolute change in FPG
Participants with HbA1c below 7% Week 12 and 26 Percentage of participants with HbA1c below 7%
Number of participants with hypoglycemia events Baseline to Week 26 Number of participants with at least 1 hypoglycemia event
Change in Treatment satisfaction Baseline to Week 26 Change in treatment satisfaction as measured by insulin treatment satisfaction questionnaire
Number of participants with health care utilization Baseline to Week 26 Number of participants with health care utilization, including hospitalization, emergency room visits, and office \[or specialty\] visits
Change in fasting SMPG Baseline to Week 26 Absolute change in fasting SMPG
Trial Locations
- Locations (14)
Investigational site Argentina
🇦🇷Buenos Aires, Argentina
investigational site Egypt
🇪🇬Egypt, Egypt
investigational site INDIA
🇮🇳India, India
investigational site COLOMBIA
🇨🇴Colombia, Colombia
Investigational site Indonesia
🇮🇩Indonesia, Indonesia
Investigational site Malaysia
🇲🇾Putrajaya, Malaysia
investigational site LEBANON
🇱🇧Lebanon, Lebanon
Investigational site PERU
🇵🇪Peru, Peru
investigational site PHILIPPINES
🇵🇭Philippines, Philippines
Investigational site Saudi Arabia
🇸🇦Saudi Arabia, Saudi Arabia
Investigational site South Africa
🇿🇦South Africa, South Africa
Investigational site Thailand
🇹🇭Thailand, Thailand
investigational site TURKEY
🇹🇷Turkey, Turkey
investigational site HONG KONG
🇭🇰Hong Kong, Hong Kong