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

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ClinicalTrials.gov Identifier: NCT04893148
Recruitment Status : Active, not recruiting
First Posted : May 19, 2021
Last Update Posted : July 20, 2022
Sponsor:
Information provided by (Responsible Party):
Eu Jeong Ku, Chungbuk National University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Glucose, High Blood Drug: IGlarLixi Drug: Dulaglutide Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 26, 2020
Actual Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: Insulin Glargine


Outcome Measures
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Primary Outcome Measures :
  1. Changes in glycated hemoglobin (HbA1c) [ Time Frame: Baseline, week 12 ]
    HbA1c will be measured at baseline and week 12


Secondary Outcome Measures :
  1. Changes in fasting plasma glucose (FPG) [ Time Frame: Baseline, week 12 ]
    Comparison of FPG changes in week 12 from baseline between the two groups

  2. Changes in glucose time in range (TIR) [ Time Frame: Baseline, week 12 ]
    Comparison of %TIR changes in week 12 from baseline between the two groups

  3. Changes in glucose time above range (TAR) [ Time Frame: Baseline, week 12 ]
    Comparison of %TAR changes in week 12 from baseline between the two groups

  4. Changes in glucose time below range (TBR) [ Time Frame: Baseline, week 12 ]
    Comparison of %TBR changes in week 12 from baseline between the two groups

  5. Incidence of hypoglycemia [ Time Frame: Baseline, week 12 ]
    Comparison of the incidence of hypoglycemia between the two groups

  6. Changes in weight [ Time Frame: Baseline, week 12 ]
    Comparison of weight changes in week 12 from baseline between the two


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04893148


Locations
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Korea, Republic of
Chungbuk National University Hospital
Cheonju, Chungcheongbuk-do, Korea, Republic of, 28644
Sponsors and Collaborators
Chungbuk National University Hospital
Investigators
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Principal Investigator: Eu Jeong Ku, MD, PhD Chungbuk National University Hospital
More Information
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Responsible Party: Eu Jeong Ku, Clinical Associate Professor, Chungbuk National University Hospital
ClinicalTrials.gov Identifier: NCT04893148    
Other Study ID Numbers: GLP1RA2021
First Posted: May 19, 2021    Key Record Dates
Last Update Posted: July 20, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eu Jeong Ku, Chungbuk National University Hospital:
IGlarLixi
Dulaglutide
Continuous glucose monitoring system
Type 2 diabetes mellitus
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin Glargine
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs