At a glance
ClinicalIndex Comparison Record- ✓Age ≥18 years at informed consent
- ✓Type 2 Diabetes Mellitus diagnosed ≥1 year before screening
- ✓Stable metformin monotherapy (≥1000 mg/day or max tolerated dose) or metformin plus one additional oral antidiabetic agent (SU, glinide, alpha-GI, DPP-4i, or SGLT-2i) for ≥3 months prior to screening
- ✓HbA1c 7.5–11% (if on metformin ± SGLT-2i) or 7.0–10% (if on metformin + other second agent)
- ✕eGFR <30 mL/min/1.73 m² (severe renal impairment)
- ✕Pregnant or breastfeeding
- ✕Prior insulin treatment (except ≤14 days for acute illness) within 1 year of screening
- ✕History of GLP-1 RA discontinuation due to safety/tolerability or lack of efficacy
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, 24 Weeks, Active-controlled, Open-label, 2-arm Multicenter Study Comparing the Efficacy and Safety of iGlarLixi to IDegAsp in Chinese Type 2 Diabetes Mellitus Participants Insufficiently Controlled With Oral Antidiabetic Drug(s)
In Brief
A Phase 3 clinical trial evaluating Insulin glargine/Lixisenatide, IDegAsp, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 582 participants across 60 sites.
Detailed Summary
This was a parallel-group treatment, Phase 3, randomized, 2-arm study that assessed the efficacy and safety of iGlarLixi to IDegAsp in Chinese T2DM participants insufficiently controlled with oral antidiabetic drug(s). Study details included: * Study duration per participant: approximately up to 27 weeks * Treatment duration: 24 weeks * Visit frequency: after screening (an on-site visit), on-site or phone call visit every 1 week from randomization till Week 4, every 2 weeks till week 12 and then every 3 weeks till Week 24 (End of Treatment). There were 14 visits that included 7 phone calls and 7 on-site visits in total during screening and treatment periods. There was a safety follow-up by a phone call visit (End of Study) in 3 days after the last dose of the treatment. * Health measurement/Observation: change in HbA1c as the primary endpoint. * Intervention name: iGlarLixi and IDegAsp * Participant sex: male and female * Participant age range: adults at least 18 years of age * Condition/disease: Type 2 diabetes mellitus
Study Details
Timeline
Interventions
solution, by subcutaneous injection
solution, by subcutaneous injection
Tablet, orally
Tablet, orally