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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus; Glucose, High Blood
• Intervention / Treatment: Drug: IGlarLixi; Drug: Dulaglutide

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 Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Chungcheongbuk-do
    • Cheonju, Chungcheongbuk-do, Korea, Republic of, 28644
      • Chungbuk National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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: Insulin Glargine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycated hemoglobin (HbA1c)	HbA1c will be measured at baseline and week 12	Baseline, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in fasting plasma glucose (FPG)	Comparison of FPG changes in week 12 from baseline between the two groups	Baseline, week 12
Changes in glucose time in range (TIR)	Comparison of %TIR changes in week 12 from baseline between the two groups	Baseline, week 12
Changes in glucose time above range (TAR)	Comparison of %TAR changes in week 12 from baseline between the two groups	Baseline, week 12
Changes in glucose time below range (TBR)	Comparison of %TBR changes in week 12 from baseline between the two groups	Baseline, week 12
Incidence of hypoglycemia	Comparison of the incidence of hypoglycemia between the two groups	Baseline, week 12
Changes in weight	Comparison of weight changes in week 12 from baseline between the two	Baseline, week 12

Collaborators and Investigators

• Sponsor: Chungbuk National University Hospital
• Investigators: Principal Investigator: Eu Jeong Ku, MD, PhD, Chungbuk National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Anticipated): December 30, 2022

Study Registration Dates

• First Submitted: May 14, 2021
• First Submitted That Met QC Criteria: May 14, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): July 20, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Type 2 diabetes mellitus; Continuous glucose monitoring system; Dulaglutide; IGlarLixi
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Dulaglutide; Insulin Glargine
• Other Study ID Numbers: GLP1RA2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No