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NCT03737240 · ClinicalTrials.gov registry record · Phase 3
IDegLira HIGH Trial
A Phase 3 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 145
- Enrollment target
NCT03737240 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 145 participants.
The verdict
NCT03737240, a Phase 3 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 145 participants
- Enrollment target
Study Summary
Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c \>9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical need for a simpler treatment regimen that could overcome these limitations. IDegLira, a fixed-ratio combination (FRC) therapy consisting of insulin degludec and liraglutide, is an attractive option for this population given its proven benefits on glycemic control, weight and compliance. This study aims to show that a simpler regimen using a novel FRC agent (IDegLira) can improve glycemic control, decrease hypoglycemia, reduce the burden of diabetes care, and improve satisfaction/adherence in patients with poorly controlled T2D with HbA1c between ≥ 9-12%. This open-label, treat-to- target, two-arm parallel, controlled trial will randomize participants with T2D and HbA1c ≥ 9%, treated with oral anti-diabetic agents and/or basal insulin therapy to lDegLira or basal-bolus insulin for 26 weeks.
Interventions
- DRUG Insulin Aspart
- DRUG IDegLira
- DRUG Insulin Degludec (U-100)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 145 participants |
| Start Date | 2019-01-15 |
| Est. Completion | 2022-07-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03737240
The ClinicalTrials.gov registry entry for NCT03737240 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 145 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Insulin Aspart is the first listed.
NCT03737240 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03737240 about?
NCT03737240 is a clinical study titled "IDegLira HIGH Trial". Basal-bolus insulin therapy is recommended for patients with poorly controlled type 2 diabetes (T2D) and HbA1c \>9%. However, basal-bolus insulin is labor intensive and associated with increased risk of hypoglycemia, glycemic variability, weight gain and poor compliance. Thus, there is a critical ne...
What is the current status of trial NCT03737240?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 145 participants. The study started on 2019-01-15. Estimated completion is 2022-07-08.
What interventions are being tested in trial NCT03737240?
The interventions under investigation include: Insulin Aspart (DRUG), IDegLira (DRUG), Insulin Degludec (U-100) (DRUG).
Who is sponsoring clinical trial NCT03737240?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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