Type 2 Diabetes Mellitus, Glucose, High Blood
Conditions
Keywords
IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus
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.
Interventions
DRUGIGlarLixi
Changing to iGlarLixi from insulin glargine
DRUGDulaglutide
Add dulaglutide to insulin glargine
Sponsors
Chungbuk National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in glycated hemoglobin (HbA1c) | Baseline, week 12 | HbA1c will be measured at baseline and week 12 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 below range (TBR) | Baseline, week 12 | Comparison of %TBR changes in week 12 from baseline between the two groups |
Countries
South Korea
Outcome results
None listed