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COMPLETED 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

NCT00662857 · View on ClinicalTrials.gov ↗

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).

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

FieldValue
Enrollment Target 29 participants
Start Date 2008-04
Est. Completion 2008-12
Phase Phase 2

Sponsor

Mannkind Corporation

39 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00662857

The ClinicalTrials.gov registry entry for NCT00662857 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 29 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Mannkind Corporation, which has 39 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00662857 reports 2 study locations spanning 2 distinct geographic areas — top geographies include California, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00662857?

This trial is sponsored by Mannkind Corporation, which has 39 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial