Status:
UNKNOWN
Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
Lead Sponsor:
Chungbuk National University Hospital
Conditions:
Type 2 Diabetes Mellitus
Glucose, High Blood
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The investigators aimed to compare efficacy and safety of IGlarLixi and insulin glargine plus dulaglutide as intensification from basal insulin with metformin, in the absence of head-to-head trials.
Detailed Description
Fixed-dose combinations of insulin glargine/lixisenatide (IGlarLixi) or insulin glargine plus dulaglutide constitute treatment intensification in type 2 diabetes mellitus (T2D). The investigators aime...
Eligibility Criteria
Inclusion
- Age ≥ 18 years old
- Patient with type 2 diabetes, treated with basal insulin plus metformin (maximum tolerated dosage) for at least 12 weeks
- Patient accepting to participant to this study
Exclusion
- Pregnant or breastfeeding woman
- severe renal dysfunction (eGFR \<60 ml/min/1.73m2)
- chronic or acute hepatic disorder (HBV or HCV hepatitis, liver cirrhosis etc.) (AST/ALT \> 2.5\*ULN)
- Prescription such as immunosuppressant agents, glucocorticoids
- Active anti-cancer treatment
Key Trial Info
Start Date :
May 26 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04893148
Start Date
May 26 2020
End Date
December 30 2022
Last Update
July 20 2022
Active Locations (1)
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1
Chungbuk National University Hospital
Cheonju, North Chungcheong, South Korea, 28644