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

Primary Purpose

Type 2 Diabetes Mellitus, Glucose, High Blood

Status
Active
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
IGlarLixi
Dulaglutide
Sponsored by
Chungbuk National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chungbuk National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

iGlar/Lixi

Dulaglutide plus insulin glargine

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Changes in glycated hemoglobin (HbA1c)
HbA1c will be measured at baseline and week 12

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2021
Last Updated
July 19, 2022
Sponsor
Chungbuk National University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04893148
Brief Title
Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 26, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chungbuk National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Glucose, High Blood
Keywords
IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iGlar/Lixi
Arm Type
Active Comparator
Arm Description
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
Arm Title
Dulaglutide plus insulin glargine
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IGlarLixi
Intervention Description
Changing to iGlarLixi from insulin glargine
Intervention Type
Drug
Intervention Name(s)
Dulaglutide
Other Intervention Name(s)
Insulin Glargine
Intervention Description
Add dulaglutide to insulin glargine
Primary Outcome Measure Information:
Title
Changes in glycated hemoglobin (HbA1c)
Description
HbA1c will be measured at baseline and week 12
Time Frame
Baseline, week 12
Secondary Outcome Measure Information:
Title
Changes in fasting plasma glucose (FPG)
Description
Comparison of FPG changes in week 12 from baseline between the two groups
Time Frame
Baseline, week 12
Title
Changes in glucose time in range (TIR)
Description
Comparison of %TIR changes in week 12 from baseline between the two groups
Time Frame
Baseline, week 12
Title
Changes in glucose time above range (TAR)
Description
Comparison of %TAR changes in week 12 from baseline between the two groups
Time Frame
Baseline, week 12
Title
Changes in glucose time below range (TBR)
Description
Comparison of %TBR changes in week 12 from baseline between the two groups
Time Frame
Baseline, week 12
Title
Incidence of hypoglycemia
Description
Comparison of the incidence of hypoglycemia between the two groups
Time Frame
Baseline, week 12
Title
Changes in weight
Description
Comparison of weight changes in week 12 from baseline between the two
Time Frame
Baseline, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eu Jeong Ku, MD, PhD
Organizational Affiliation
Chungbuk National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chungbuk National University Hospital
City
Cheonju
State/Province
Chungcheongbuk-do
ZIP/Postal Code
28644
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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