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

Chungbuk National University Hospital40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 2 Diabetes Mellitus Glucose, High Blood

Interventions

IGlarLixiDRUG

Changing to iGlarLixi from insulin glargine

DulaglutideDRUG

Add dulaglutide to insulin glargine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Chungbuk National University Hospital

Cheonju, North Chungcheong, South Korea

Outcomes

Primary Outcomes

Changes in glycated hemoglobin (HbA1c)

HbA1c will be measured at baseline and week 12

Time frame: Baseline, week 12

Secondary Outcomes

Changes in fasting plasma glucose (FPG)

Comparison of FPG changes in week 12 from baseline between the two groups

Time frame: Baseline, week 12

Changes in glucose time in range (TIR)

Comparison of %TIR changes in week 12 from baseline between the two groups

Time frame: Baseline, week 12

Changes in glucose time above range (TAR)

Comparison of %TAR changes in week 12 from baseline between the two groups

Time frame: Baseline, week 12

Changes in glucose time below range (TBR)

Comparison of %TBR changes in week 12 from baseline between the two groups

Time frame: Baseline, week 12

Incidence of hypoglycemia

Comparison of the incidence of hypoglycemia between the two groups

Time frame: Baseline, week 12

Changes in weight

Comparison of weight changes in week 12 from baseline between the two

Time frame: Baseline, week 12

Data from ClinicalTrials.gov

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