NCT04893148

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

Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes Insufficiently Controlled by Insulin Glargine and Metformin Combination Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Chungbuk National University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus
• Glucose, High Blood

Interventions

Type	Name	Description
DRUG	IGlarLixi	Changing to iGlarLixi from insulin glargine
DRUG	Dulaglutide	Add dulaglutide to insulin glargine

Timeline

• Start date: 2020-05-26
• Primary completion: 2021-12-30
• Completion: 2022-12-30
• First posted: 2021-05-19
• Last updated: 2022-07-20

Locations

1 site across 1 country: South Korea