Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
NCT ID: NCT04893148
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
40 participants
INTERVENTIONAL
2020-05-26
2022-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
IGlarLixi
Changing to iGlarLixi from insulin glargine
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.
Dulaglutide
Add dulaglutide to insulin glargine
Interventions
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IGlarLixi
Changing to iGlarLixi from insulin glargine
Dulaglutide
Add dulaglutide to insulin glargine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Chungbuk National University Hospital
OTHER
Responsible Party
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Eu Jeong Ku
Clinical Associate Professor
Principal Investigators
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Eu Jeong Ku, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Chungbuk National University Hospital
Locations
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Chungbuk National University Hospital
Cheonju, North Chungcheong, South Korea
Countries
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Other Identifiers
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GLP1RA2021
Identifier Type: -
Identifier Source: org_study_id
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