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NCT00662857 · ClinicalTrials.gov registry record · Phase 2
A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro
A Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 29
- Enrollment target
- 2
- Study locations
NCT00662857: Completed Phase 2 study of Diabetes Mellitus, Type 1, sponsored by Mannkind Corporation.
NCT00662857 is a Phase 2 study of Diabetes Mellitus, Type 1 that has completed, run by Mannkind Corporation. The registered enrollment target is 29 participants, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00662857, a Phase 2 study of Diabetes Mellitus, Type 1, has completed, sponsored by Mannkind Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 29 participants
- Enrollment target
- 2
- Study locations
Study Summary
28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).
Primary Outcome
Dose-normalized baseline-corrected area under the serum insulin vs. time curve
Conditions Studied
Interventions
- DRUG Technosphere® Insulin Inhalation Powder
- DRUG Technosphere Insulin® Inhalation Powder
- DRUG RAA Population
Study Locations (2)
California
- Profil Institute for Clinical Research Inc. - Chula Vista
Texas
- Diabetes & Glandular Disease Research Assoc PA - San Antonio
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2008-04 |
| Est. Completion | 2008-12 |
| Phase | Phase 2 |
What the finished NCT00662857 record still lists
NCT00662857 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 1,266-participant average among 118 other Diabetes Mellitus, Type 1 trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Diabetes Mellitus, Type 1 appearing as the primary indexed condition, and to 3 interventions - of which Technosphere® Insulin Inhalation Powder is the first listed.
NCT00662857 reports a single indexed study location in California, Texas.
Frequently Asked Questions
What is clinical trial NCT00662857 about?
NCT00662857 is a clinical study titled "A Study Designed to Compare 2 Dose Strengths of TI Inhalation Powder in Adults With Type 1 Diabetes Mellitus and to Compare One of Those Formulations (30Units) With an Injection of Insulin Lispro". 28 subjects to be enrolled for a screening period, 3 dosing visits \& a follow-up visit. Visits 2 and 3 dosing of TI Inhalation Powder, cross over between two 15 U cartridges and one 30 U cartridge. Visit 4 dosing will be a sc injection of 10 IU of RAA (rapid-acting insulin analogue).
What is the current status of trial NCT00662857?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 29 participants. The study started on 2008-04. Estimated completion is 2008-12.
What conditions does trial NCT00662857 study?
This clinical trial studies the following conditions: Diabetes Mellitus, Type 1.
What interventions are being tested in trial NCT00662857?
The interventions under investigation include: Technosphere® Insulin Inhalation Powder (DRUG), Technosphere Insulin® Inhalation Powder (DRUG), RAA Population (DRUG).
Who is sponsoring clinical trial NCT00662857?
This trial is sponsored by Mannkind Corporation, which has 42 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00662857 being conducted?
This trial has 2 study locations across California, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetes Mellitus, Type 1
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00662857's enrollment target sits among peer trials
29 90th of 118 higher than 28 of 118 other Diabetes Mellitus, Type 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetes Mellitus, Type 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.
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