This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.
The study duration will be up to 27 weeks, with a treatment duration approximately 24 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
105
iGlarLixi is available as a sterile solution for injection that will be administered to study participants subcutaneously
Investigational Site Number : 3560007
Delhi, India
Investigational Site Number : 3560005
Hyderabad, India
Investigational Site Number : 3560006
Indore, India
Investigational Site Number : 3560011
Jaipur, India
Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)
Time frame: From Day 1 to Week 25
Mean change in hemoglobin A1c (HbA1c)
Time frame: From baseline to the end of 6 months
Mean change in fasting plasma glucose (FPG)
Time frame: From baseline to the end of 3 months and 6 months
Mean change in 2 hours postprandial plasma glucose (PPG)
Time frame: From baseline to the end of 3 months and 6 months
Mean change in fasting Self-Monitoring Plasma Glucose (SMPG)
Time frame: From baseline to the end of 3 months and 6 months
Change in mean dose of iGlarLixi
Time frame: From baseline to the end of 6 months
Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile
Time frame: From baseline to the end of 3 months and 6 months
Mean change in bodyweight
Time frame: From baseline to the end of 6 months
Percentage of participants with at least one hypoglycaemic episode
Hypoglycaemic episodes: American Diabetes Association (ADA) level 1, 2 or 3
Time frame: From Day 1 to Week 25
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site Number : 3560003
Kanpur, India
Investigational Site Number : 3560001
Kolkata, India
Investigational Site Number : 3560008
Pune, India
Investigational Site Number: 3560013
Pune, India
Investigational Site Number : 3560014
Visakhapatnam, India