Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

December 20, 2007 updated by: Eli Lilly and Company

Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus

This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

119

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Colorado
      • Denver, Colorado, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Florida
      • Hollywood, Florida, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New Port Richey, Florida, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Ocala, Florida, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Pembroke Pines, Florida, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Georgia
      • Atlanta, Georgia, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Idaho
      • Idaho Falls, Idaho, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Illinois
      • Springfield, Illinois, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Maryland
      • Baltimore, Maryland, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Massachusetts
      • Jackson, Massachusetts, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Missouri
      • Chesterfield, Missouri, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Nebraska
      • Omaha, Nebraska, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New Hampshire
      • Hamptom, New Hampshire, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • New York
      • Flushing, New York, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • New Hyde Park, New York, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • North Carolina
      • Greenville, North Carolina, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Oregon
      • Salem, Oregon, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • South Carolina
      • Columbia, South Carolina, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Texas
      • Dallas, Texas, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • San Antonio, Texas, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • Washington
      • Federal Way, Washington, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Renton, Washington, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
      • Tacoma, Washington, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
    • West Virginia
      • Charleston, West Virginia, United States
        • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • You are at least 18 years old.
  • You have had type 1 diabetes for at least 2 years.
  • You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
  • If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
  • You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.

Exclusion Criteria:

  • You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
  • You have a history of asthma or allergies.
  • You have a chronic cough.
  • You have had a kidney transplant, are on dialysis, or have poor kidney function.
  • You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: B
Drug: human insulin inhalation powder (HIIP)
  • Administer HIIP within 15 minutes before meals.
  • Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin.
  • Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin
Other Names:
  • LY041001
Experimental: A
Drug: insulin
  • Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals.
  • Inject into abdomen only.
Other Names:
  • LY041001

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
test the hypothesis that preprandial HIIP plus insulin glargine is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) plus insulin glargine with respect to HbA1c
Time Frame: 12 weeks per therapy
12 weeks per therapy

Secondary Outcome Measures

Outcome Measure
compare the pharmacokinetics of test doses of preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro) administered to a subgroup of patients
compare 7-point self-monitored blood glucose profiles (blood glucose measurements before & 2 hours after start of morning, midday, evening meals, and blood glucose measurement at bedtime) for preprandial HIIP and preprandial inject
assess the safety of HIIP using pulmonary function tests, chest x rays, insulin antibody titers, adverse events (AEs), and episodes of hypoglycemia
assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments
compare insulin dose requirements (both preprandial and basal insulin [insulin glargine]) of patients administering preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro
assess insulin inhaler reliability
assess patient compliance with the HIIP delivery system Directions for Use (DFU)
assess the impact of practice inhalations on inspiratory flow parameters (peak inspiratory flow rate [IFR] and total inspired volume [TIV]) achieved by patients using the insulin inhaler following training with the DFU

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

Alkermes, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2003

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

June 20, 2003

First Submitted That Met QC Criteria

June 24, 2003

First Posted (Estimate)

June 25, 2003

Study Record Updates

Last Update Posted (Estimate)

December 21, 2007

Last Update Submitted That Met QC Criteria

December 20, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6944
  • H7U-MC-IDAI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus, Type 1

Clinical Trials on insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe