Trial · Interventional
CompletedPhase 4Registry dataA Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
Overview
- Status
- Completed
- Phase
- Phase 4
- Enrollment
- 105 participants (actual)
- Sponsor
- Sanofi · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
India
- Start
- 6 Jan 2025
- Primary completion
- 12 Jun 2026
- Completion
- 12 Jun 2026
- First posted
- 4 Dec 2024
- Last update posted
- 10 Jul 2026
- Conditions
- Type 2 Diabetes
Timeline
1 trial · 1 completed
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
A Study to Investigate Safety and Efficacy of iGlarLixi in Adult Patients With Type 2 Diabetes Mellitus
NCT067164246 Jan 2025 to 12 Jun 2026
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This is an intervention, phase IV, single-arm study to assess the safety and efficacy of iGlarLixi in adult patients with Type 2 diabetes.
Interventions
- iGlarLixi (insulin glargine/lixisenatide)Drug
Arms1
Experimental
iGlarLixi
iGlarLixi will be administered to study participants subcutaneously
Primary outcomes1
Outcomes the sponsor listed as primary.
Percentage of participants with treatment emergent adverse events (TEAEs) including serious adverse events (SAEs)
Time frame · From Day 1 to Week 25
Secondary outcomes(8)
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
Time frame · From Day 1 to Week 25
Registry description
Hypoglycaemic episodes: American Diabetes Association (ADA) level 1, 2 or 3
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
Completed trials do not always post results.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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