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

NCT04893148 | Unknown Phase 4 DMC

• 1 other identifier: GLP1RA2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Glucose, High Blood

Keywords

IGlarLixi; Dulaglutide; Continuous glucose monitoring system; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Changes in glycated hemoglobin (HbA1c)

  HbA1c will be measured at baseline and week 12

  Baseline, week 12

Secondary Outcomes (6)

• Changes in fasting plasma glucose (FPG)

  Baseline, week 12

• Changes in glucose time in range (TIR)

  Baseline, week 12

• Changes in glucose time above range (TAR)

  Baseline, week 12

• Changes in glucose time below range (TBR)

  Baseline, week 12

• Incidence of hypoglycemia

  Baseline, week 12

Study Arms (2)

iGlar/Lixi

ACTIVE COMPARATOR

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

Dulaglutide plus insulin glargine

ACTIVE COMPARATOR

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

Interventions

IGlarLixi DRUG

Changing to iGlarLixi from insulin glargine

iGlar/Lixi

Dulaglutide DRUG

Add dulaglutide to insulin glargine

Also known as: Insulin Glargine

Dulaglutide plus insulin glargine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chungbuk National University Hospital: lead

Study Sites (1)

Chungbuk National University Hospital

Cheonju, North Chungcheong, 28644, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

dulaglutide; Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Eu Jeong Ku, MD, PhD

  Chungbuk National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: May 14, 2021
• First Posted: May 19, 2021
• Study Start: May 26, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Locations

KR (1)