Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes

Sponsor
Chungbuk National University Hospital
Study ID
NCT04893148
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • IGlarLixi — DRUG
    Changing to iGlarLixi from insulin glargine
  • Dulaglutide — DRUG
    Add dulaglutide to insulin glargine

Study Details

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.

Key Dates

Start date
May 26, 2020
Status verified
Jul 2022
Primary completion
Dec 30, 2021
Completion
Dec 30, 2022

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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
  • Active Comparator: 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.

Primary Outcome Measure

Changes in glycated hemoglobin (HbA1c) [ Time Frame: Baseline, week 12 ]

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