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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04893148
• Other study ID #: GLP1RA2021
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: May 26, 2020
• Est. completion date: December 30, 2022

Study information

• Verified date: July 2022
• Source: Chungbuk National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Glucose, High Blood
• Type 2 Diabetes Mellitus

Intervention

Drug:
• IGlarLixi
Changing to iGlarLixi from insulin glargine
• Dulaglutide
Add dulaglutide to insulin glargine

Locations

Country	Name	City	State
Korea, Republic of	Chungbuk National University Hospital	Cheonju	Chungcheongbuk-do

Sponsors (1)

Lead Sponsor	Collaborator
Chungbuk National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glycated hemoglobin (HbA1c)	HbA1c will be measured at baseline and week 12	Baseline, week 12
Secondary	Changes in fasting plasma glucose (FPG)	Comparison of FPG changes in week 12 from baseline between the two groups	Baseline, week 12
Secondary	Changes in glucose time in range (TIR)	Comparison of %TIR changes in week 12 from baseline between the two groups	Baseline, week 12
Secondary	Changes in glucose time above range (TAR)	Comparison of %TAR changes in week 12 from baseline between the two groups	Baseline, week 12
Secondary	Changes in glucose time below range (TBR)	Comparison of %TBR changes in week 12 from baseline between the two groups	Baseline, week 12
Secondary	Incidence of hypoglycemia	Comparison of the incidence of hypoglycemia between the two groups	Baseline, week 12
Secondary	Changes in weight	Comparison of weight changes in week 12 from baseline between the two	Baseline, week 12