Type 2 Diabetes MellitusPhase 4NCT04893148
Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
A Phase 4 study testing IGlarLixi and Dulaglutide in people with Type 2 Diabetes Mellitus and Glucose, High Blood, run by Chungbuk National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus, Glucose, High Blood
- What is being tested?
- IGlarLixi and Dulaglutide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 26 May 2020to 30 Dec 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Chungbuk National University Hospital
Cheonju, North Chungcheong, 28644
About this study
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
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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Glucose, High Blood
- Being tested
- IGlarLixi, Dulaglutide
- Keywords
- IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGlarLixiDrug
Changing to iGlarLixi from insulin glargine
DulaglutideDrug
Also called Insulin Glargine
Add dulaglutide to insulin glargine
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Drug: Dulaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glycated hemoglobin (HbA1c)
HbA1c will be measured at baseline and week 12
Measured: Baseline, week 12
Secondary outcomes (6)
Changes in fasting plasma glucose (FPG)
Comparison of FPG changes in week 12 from baseline between the two groups
Measured: Baseline, week 12
Changes in glucose time in range (TIR)
Comparison of %TIR changes in week 12 from baseline between the two groups
Measured: Baseline, week 12
Changes in glucose time above range (TAR)
Comparison of %TAR changes in week 12 from baseline between the two groups
Measured: Baseline, week 12
Changes in glucose time below range (TBR)
Comparison of %TBR changes in week 12 from baseline between the two groups
Measured: Baseline, week 12
Incidence of hypoglycemia
Comparison of the incidence of hypoglycemia between the two groups
Measured: Baseline, week 12
Changes in weight
Comparison of weight changes in week 12 from baseline between the two
Measured: Baseline, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start26 May 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chungbuk National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eu Jeong Ku, Chungbuk National University Hospital
- Investigators
- Eu Jeong Ku, MD, PhD, Principal investigator, Chungbuk National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04893148
- Sponsor's protocol ID
- GLP1RA2021
- Status last verified
- Jul 2022
- First submitted
- 14 May 2021
- Last updated
- 20 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04893148
- Acronym / sponsor ID
- GLP1RA2021
- Conditions
- Type 2 Diabetes Mellitus, Glucose, High Blood
- Keywords
- IGlarLixi, Dulaglutide, Continuous glucose monitoring system, Type 2 diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chungbuk National University HospitalUniversity, hospital or other
- Study start
- 26 May 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iGlar/Lixi | Active comparator | Drug: IGlarLixiSwitching 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 |
| Dulaglutide plus insulin glargine | Active comparator | Drug: DulaglutideAdding 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IGlarLixiChanging to iGlarLixi from insulin glargine | Drug | iGlar/Lixi |
| DulaglutideAlso: Insulin GlargineAdd dulaglutide to insulin glargine | Drug | Dulaglutide plus insulin glargine |
Primary outcome
Changes in glycated hemoglobin (HbA1c)
Time frame: Baseline, week 12
HbA1c will be measured at baseline and week 12
6 secondary outcomes
Changes in fasting plasma glucose (FPG)
Time frame: Baseline, week 12
Changes in glucose time in range (TIR)
Time frame: Baseline, week 12
Changes in glucose time above range (TAR)
Time frame: Baseline, week 12
Changes in glucose time below range (TBR)
Time frame: Baseline, week 12
Incidence of hypoglycemia
Time frame: Baseline, week 12
Changes in weight
Time frame: Baseline, week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eu Jeong Ku, MD, PhD principal investigator
Chungbuk National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IGlarLixi and Dulaglutide in people with Type 2 Diabetes Mellitus and Glucose, High Blood, run by Chungbuk National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in glycated hemoglobin (HbA1c) (time frame: Baseline, week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2022.