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NCT02794155 · ClinicalTrials.gov registry record · Phase 2
Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)
A Phase 2 study, sponsored by Diasome Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 157
- Enrollment target
NCT02794155: Completed Phase 2 study, sponsored by Diasome Pharmaceuticals.
NCT02794155 is a Phase 2 study that has completed, run by Diasome Pharmaceuticals. The registered enrollment target is 157 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02794155, a Phase 2 study, has completed, sponsored by Diasome Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 157 participants
- Enrollment target
Study Summary
This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally allocated randomization scheme to 1 of the 2 treatment arms in an overall 2:1 scheme (HDV Insulin Lispro: Insulin Lispro). Both arms will receive the randomized treatment in combination with glargine or detemir. Goal to demonstrate that the efficacy of HDV insulin lispro administered in combination with a basal insulin (HDV Insulin Lispro group) is non-inferior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on glycated hemoglobin (HbA1c) in patients with type 1 diabetes. If non-inferiority is demonstrated, confirm that HDV insulin lispro in combination with a basal insulin (HDV Insulin Lispro group) is superior to insulin lispro in combination with a basal insulin (Insulin Lispro group), in effects on HbA1c in patients with type 1 diabetes (≥ 0.4% decrease in HbA1c).
Primary Outcome
Change in HbA1c from Week 0 to Week 13, from Week 0 to Week 26, and from Week 13 to Week 26
Interventions
- DRUG HDV Insulin Lispro
- DRUG Insulin LISPRO
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 157 participants |
| Start Date | 2016-06 |
| Est. Completion | 2018-06-15 |
| Phase | Phase 2 |
What the finished NCT02794155 record still lists
NCT02794155 is an interventional study that assigns participants to a tested intervention. The registered 157 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which HDV Insulin Lispro is the first listed.
NCT02794155 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02794155 about?
NCT02794155 is a clinical study titled "Study of HDV Insulin Versus Insulin in Type 1 Diabetes Subjects (ISLE-1)". This will be a Phase 2b, multicenter, randomized, double blind, titration clinical study, evaluating the efficacy and safety in the HDV Insulin Lispro Group versus Insulin Lispro Group in patients with type 1 diabetes over a 26 week treatment period. The patients will be randomized using a centrally...
What is the current status of trial NCT02794155?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 157 participants. The study started on 2016-06. Estimated completion is 2018-06-15.
What interventions are being tested in trial NCT02794155?
The interventions under investigation include: HDV Insulin Lispro (DRUG), Insulin LISPRO (DRUG).
Who is sponsoring clinical trial NCT02794155?
This trial is sponsored by Diasome Pharmaceuticals, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02794155's enrollment target sits among peer trials
157 443rd of 2000 higher than 1,556 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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