Trial · Interventional
Status unknownPhase 4Registry dataEfficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
Overview
- Status
- Status unknown
- Phase
- Phase 4
- Enrollment
- 40 participants (estimated)
- Sponsor
- Chungbuk National University Hospital · Other
- Design
- Randomized · Open label (no masking)
- Countries
1 country
South Korea
- Start
- 26 May 2020
- Primary completion
- 30 Dec 2021
- Completion
- 30 Dec 2022 (estimated)
- First posted
- 19 May 2021
- Last update posted
- 20 Jul 2022
- Conditions
- Type 2 Diabetes Mellitus · Glucose, High Blood
Timeline
1 trial
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 4
Efficacy and Safety of iGlarLixi Versus Insulin Glargine Plus Dulaglutide in Patients With Type 2 Diabetes
NCT0489314826 May 2020 to est. 30 Dec 2022
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- IGlarLixiDrug
- DulaglutideDrug
Arms2
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
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.
Primary outcomes1
Outcomes the sponsor listed as primary.
Changes in glycated hemoglobin (HbA1c)
Time frame · Baseline, week 12
Registry description
HbA1c will be measured at baseline and week 12
Secondary outcomes(6)
Changes in fasting plasma glucose (FPG)
Time frame · Baseline, week 12
Registry description
Comparison of FPG changes in week 12 from baseline between the two groups
Changes in glucose time in range (TIR)
Time frame · Baseline, week 12
Registry description
Comparison of %TIR changes in week 12 from baseline between the two groups
Changes in glucose time above range (TAR)
Time frame · Baseline, week 12
Registry description
Comparison of %TAR changes in week 12 from baseline between the two groups
Changes in glucose time below range (TBR)
Time frame · Baseline, week 12
Registry description
Comparison of %TBR changes in week 12 from baseline between the two groups
Incidence of hypoglycemia
Time frame · Baseline, week 12
Registry description
Comparison of the incidence of hypoglycemia between the two groups
Changes in weight
Time frame · Baseline, week 12
Registry description
Comparison of weight changes in week 12 from baseline between the two
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 18 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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