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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: Completed Phase 3 study, sponsored by Emory University.
NCT03737240 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 145 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
HbA1c will be compared between study groups. HbA1c measures the average percentage of blood sugar over the past 2 to 3 months and HbA1c can reduce with management of diabetes through diet, exercise, and medication. HbA1c levels below 5.7% are considered normal. Persons with values between 5.7% and 6.4% are considered at high risk of developing diabetes while those with values of 6.5% and above are diagnosed with diabetes. Persons with diabetes aim to get their HbA1c in the range of 7.0 to 7.5% o
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 |
What the finished NCT03737240 record still lists
NCT03737240 is an interventional study that assigns participants to a tested intervention. The registered 145 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 3 interventions - of which Insulin Aspart is the first listed.
NCT03737240 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03737240's enrollment target sits among peer trials
145 1555th of 2000 higher than 442 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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