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NCT01334151 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes
A Phase 1 study, sponsored by Biodel.
- Completed
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
NCT01334151: Completed Phase 1 study, sponsored by Biodel.
NCT01334151 is a Phase 1 study that has completed, run by Biodel. The registered enrollment target is 13 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334151, a Phase 1 study, has completed, sponsored by Biodel.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
Primary Outcome
The speed of absorption will be assessed by the time to reach 50% of maximum insulin concentration (TINS-50%-early, time before CINS max) and the onset of action will be assessed by the time to reach 50% of the maximum glucose infusion rate (TGIR-50%- early).
Interventions
- DRUG Insulin LISPRO
- DRUG recombinant human insulin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2011-03 |
| Est. Completion | 2011-08 |
| Phase | Phase 1 |
What the finished NCT01334151 record still lists
NCT01334151 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Insulin LISPRO is the first listed.
NCT01334151 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01334151 about?
NCT01334151 is a clinical study titled "Pharmacokinetic and Pharmacodynamic Properties of BIOD-105 and BIOD-107 Compared to Humalog® in Subjects With Type 1 Diabetes". The primary objective of this study is to assess the speed of absorption and onset of action of BIOD-105 and BIOD-107 and compare them to Humalog®.
What is the current status of trial NCT01334151?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2011-03. Estimated completion is 2011-08.
What interventions are being tested in trial NCT01334151?
The interventions under investigation include: Insulin LISPRO (DRUG), recombinant human insulin (DRUG).
Who is sponsoring clinical trial NCT01334151?
This trial is sponsored by Biodel, which has 6 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01334151's enrollment target sits among peer trials
13 1847th of 2000 higher than 149 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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