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Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

NCT00127634 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 385

Last updated 2018-03-09

No results posted yet for this study

Summary

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

DRUG

Human Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 24 months, up to 36 months

DRUG

Injectable Insulin

patient specific dose, injectable, before meals, 24 months, up to 36 months.

DRUG

Insulin Glargine

patient specific dose, injectable, as needed, 24 months up to 36 months

Sponsors & Collaborators

Principal Investigators

  • Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, 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
2005-07-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States
  • Belgium
  • Canada
  • Croatia
  • Hungary
  • India

Study Locations

More Related Trials

Entities

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 NCT00127634 on ClinicalTrials.gov