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Evaluate Safety of Technosphere® Insulin (TI) in Diabetic Subjects With Moderate Obstructive Pulmonary Disease

NCT00642616 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-04-14

Study results available
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Summary

Examine the effects of TI in combination with an anti-diabetic regimen including inhaled insulin versus anti-diabetic treatment without inhaled insulin on lung function \& pulmonary safety

Conditions

Interventions

DRUG

Technosphere® Insulin

Technosphere® Insulin delivered with Gen 2 inhaler with doses individualized for each participant in combination with an antidiabetic regimen of insulin and/or oral antidiabetic agents

DRUG

Usual Care

Type 1 diabetics: long-acting (basal) insulin plus rapid-acting insulin, or pre-mix insulin Type 2 diabetics: oral anti-diabetic medications with or without long-acting (basal) insulin

Sponsors & Collaborators

  • Mannkind Corporation

    lead INDUSTRY

Principal Investigators

  • Chief Medical Officer · Mannkind Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States
  • Russia
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

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 NCT00642616 on ClinicalTrials.gov