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Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

NCT00157339 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 299

Last updated 2019-09-17

No results posted yet for this study

Summary

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Conditions

Interventions

DRUG

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 12 months

DRUG

injected insulin

patient specific dose, injected, before meals, 12 months.

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) · Eli Lilly and Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-08-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Argentina
  • Bulgaria
  • Canada
  • Chile
  • Colombia
  • Croatia
  • Hong Kong
  • Hungary
  • India
  • Mexico
  • Philippines
  • Puerto Rico
  • Singapore
  • Taiwan
  • Thailand

Study Locations

More Related Trials

Entities

Diseases
Companies

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 NCT00157339 on ClinicalTrials.gov