Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
- Conditions
- Type 2 Diabetes MellitusGlucose, High Blood
- Interventions
- Registration Number
- NCT04893148
- Lead Sponsor
- Chungbuk National University Hospital
- 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 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. Treatments were compared in terms of glycated hemoglobin (HbA1c), fasting plasma glucose (FPG) change from baseline, and variables from continuous glucose monitoring (CGM) system; in addition to safety issues on hypoglycemia and changes in weight.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iGlar/Lixi IGlarLixi Switching to IGlarLixi from insulin glargine iGlar/Lixi starts with the following doses depending on the existing insulin glargine dose: 1) insulin glargine \<20 unit/day = iGlar/Lixi 10 unit/day, 2) insulin glargine \>=20 unit/day = iGlar/Lixi 20 unit/day. Training to increase the iGlar/Lixi dosage every 3 days to meet the target fasting blood glucose level to 80\~130 mg/day Dulaglutide plus insulin glargine Dulaglutide Adding Dulaglutide to insulin glargine. Keep insulin glargine and dulaglutide start at 0.75 mg per week and increase to 1.5 mg per week after 1 month with evaluating compliance and tolerability.
- Primary Outcome Measures
Name Time Method Changes in glycated hemoglobin (HbA1c) Baseline, week 12 HbA1c will be measured at baseline and week 12
- Secondary Outcome Measures
Name Time Method Changes in glucose time in range (TIR) Baseline, week 12 Comparison of %TIR changes in week 12 from baseline between the two groups
Changes in glucose time below range (TBR) Baseline, week 12 Comparison of %TBR changes in week 12 from baseline between the two groups
Changes in fasting plasma glucose (FPG) Baseline, week 12 Comparison of FPG changes in week 12 from baseline between the two groups
Incidence of hypoglycemia Baseline, week 12 Comparison of the incidence of hypoglycemia between the two groups
Changes in weight Baseline, week 12 Comparison of weight changes in week 12 from baseline between the two
Changes in glucose time above range (TAR) Baseline, week 12 Comparison of %TAR changes in week 12 from baseline between the two groups
Trial Locations
- Locations (1)
Chungbuk National University Hospital
🇰🇷Cheonju, Chungcheongbuk-do, Korea, Republic of