| Trial ID: | L4230 |
| Source ID: | NCT06716424
|
| Associated Drug: |
Iglarlixi (Insulin Glargine/Lixisenatide)
|
| Title: |
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: iGlarLixi (insulin glargine/lixisenatide)
|
| Outcome Measures: |
Primary: Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs), From Day 1 to Week 25 | Secondary: Mean change in hemoglobin A1c (HbA1c), From baseline to the end of 6 months|Mean change in fasting plasma glucose (FPG), From baseline to the end of 3 months and 6 months|Mean change in 2 hours postprandial plasma glucose (PPG), From baseline to the end of 3 months and 6 months|Mean change in fasting Self-Monitoring Plasma Glucose (SMPG), From baseline to the end of 3 months and 6 months|Change in mean dose of iGlarLixi, From baseline to the end of 6 months|Effect of iGlarLixi on 7-point Self-Monitoring Plasma Glucose (SMPG) profile, From baseline to the end of 3 months and 6 months|Mean change in bodyweight, 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, From Day 1 to Week 25
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
|
| Start Date: |
2025-01-06
|
| Completion Date: |
2025-07-21
|
| Results First Posted: |
|
| Last Update Posted: |
2025-04-04
|
| Locations: |
Investigational Site Number : 3560007, Delhi, 110088, India|Investigational Site Number : 3560005, Hyderabad, 500034, India|Investigational Site Number : 3560011, Jaipur, 302017, India|Investigational Site Number : 3560001, Kolkata, 700020, India|Investigational Site Number : 3560008, Pune, 411004, India
|
| URL: |
https://clinicaltrials.gov/show/NCT06716424
|
