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Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00356109
First Posted: July 25, 2006
Last Update Posted: February 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
  Purpose

A study to test for non-inferiority of preprandial HIIP [also known as AIR® Inhaled Insulin Powder][AIR® is a registered trademark of Alkermes,Inc.] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus.

This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes.

The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.


Condition Intervention Phase
Diabetes Mellitus, Type 1 Drug: Human Insulin Inhalation Powder Drug: Injectable insulin Drug: Insulin Glargine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint. [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • Insulin dose requirements [ Time Frame: throughout the study ]
  • Insulin antibody binding levels [ Time Frame: baseline, 1 month, 6 months, follow-up ]
  • To compare HbAlc change [ Time Frame: 6 months ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 6 months ]

Enrollment: 494
Study Start Date: August 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 6 months
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 6 months
Active Comparator: 2 Drug: Injectable insulin
patient specific dose, injected, before meals, 6 months
Drug: Insulin Glargine
patient specific dose, injectable, before meals, 6 months

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 diabetes for at least 24 months
  • Have an HbA1c less than or equal to 11%
  • Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months
  • Non-smoker

Exclusion Criteria:

  • Require a daily total insulin dosage greater than 150 U at screening
  • Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease
  • Systemic glucocorticoid therapy
  • Clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • History of lung transplantation and/or lung cancer
  • Diagnosed with pneumonia in the 3 months prior to screening
  • History of renal transplantation
  • Active or untreated malignancy
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00356109


  Show 37 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
Investigators
Study Director: 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
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00356109     History of Changes
Other Study ID Numbers: 9627
H7U-MC-IDAV
First Submitted: July 21, 2006
First Posted: July 25, 2006
Last Update Posted: February 9, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs