Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy
Trial Snapshot
- Phase
- Phase 4
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Changes in glycated hemoglobin (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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
Arms & Interventions
iGlar/Lixi
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
Intervention: IGlarLixi (Drug)
Dulaglutide plus insulin glargine
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.
Intervention: Dulaglutide (Drug)
Outcomes
Primary Outcomes
Changes in glycated hemoglobin (HbA1c)
Time Frame: Baseline, week 12
HbA1c will be measured at baseline and week 12
Secondary Outcomes
- Changes in glucose time in range (TIR)(Baseline, week 12)
- Changes in glucose time below range (TBR)(Baseline, week 12)
- Changes in fasting plasma glucose (FPG)(Baseline, week 12)
- Incidence of hypoglycemia(Baseline, week 12)
- Changes in weight(Baseline, week 12)
- Changes in glucose time above range (TAR)(Baseline, week 12)
Investigators
Eu Jeong Ku
Clinical Associate Professor
Chungbuk National University Hospital