Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 |
Drug: IGlarLixi
Changing to iGlarLixi from insulin glargine
|
| 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. |
Drug: Dulaglutide
Add dulaglutide to insulin glargine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Changes in glycated hemoglobin (HbA1c) [Baseline, week 12]
HbA1c will be measured at baseline and week 12
Secondary Outcome Measures
- Changes in fasting plasma glucose (FPG) [Baseline, week 12]
Comparison of FPG changes in week 12 from baseline between the two groups
- 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 above range (TAR) [Baseline, week 12]
Comparison of %TAR 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
- 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
Eligibility Criteria
Criteria
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
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severe renal dysfunction (eGFR <60 ml/min/1.73m2)
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chungbuk National University Hospital | Cheonju | Chungcheongbuk-do | Korea, Republic of | 28644 |
Sponsors and Collaborators
- Chungbuk National University Hospital
Investigators
- Principal Investigator: Eu Jeong Ku, MD, PhD, Chungbuk National University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GLP1RA2021