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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 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2014-10-16

Study results available
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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

  • Diabetes Mellitus: Type 1

Interventions

DRUG

Technosphere® Insulin Inhalation Powder

TI Inhalation Powder, two 15 U cartridges

DRUG

Technosphere Insulin® Inhalation Powder

TI Inhalation Powder, one 30 U cartridge

DRUG

RAA Population

RAA Population: All subjects received a single 10 IU sc injection of insulin lispro.

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-04-30
Primary Completion
2008-11-30
Completion
2008-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00662857 on ClinicalTrials.gov