Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00356109
First received: July 21, 2006
Last updated: February 6, 2009
Last verified: February 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Insulin dose requirements [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • Insulin antibody binding levels [ Time Frame: baseline, 1 month, 6 months, follow-up ] [ Designated as safety issue: No ]
  • To compare HbAlc change [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess rate and incidence of hypoglycemia [ Time Frame: 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356109

  Hide Study Locations
Locations
United States, Colorado
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Aurora, Colorado, United States, 80045
United States, Florida
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Miami, Florida, United States, 33136
United States, Georgia
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Atlanta, Georgia, United States, 30309
United States, Idaho
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Idaho Falls, Idaho, United States, 83404
United States, Illinois
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Springfield, Illinois, United States, 62704
United States, Indiana
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Indianapolis, Indiana, United States, 46250
United States, Maryland
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Baltimore, Maryland, United States, 21204
United States, Michigan
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Grand Rapids, Michigan, United States, 49503
United States, New York
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New York, New York, United States, 10025
United States, Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
United States, Texas
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Dallas, Texas, United States, 75246
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El Paso, Texas, United States, 79935
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San Antonio, Texas, United States, 78229
United States, Utah
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Ogden, Utah, United States, 84403
Argentina
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Buenos Aires, Argentina, C1213AAH
Belgium
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Aalst, Belgium, 9300
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Brussels, Belgium, 1070
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Edegem, Belgium, 2650
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Gent, Belgium, 9000
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Leuven, Belgium, 3000
France
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Angers, France, 49033
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Paris, France, 75475
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Poitiers, France, 86000
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Toulouse, France, 31054
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Tours, France, 37044
Germany
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Aschaffenburg, Germany, 63739
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Münster, Germany, 48145
India
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Bangalore, India, 560 054
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Chennai, India, 600 013
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Cochin, India, 682026
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Mumbai, India, 400 007
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New Delhi, India, 110 029
Italy
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Milano, Italy, 20142
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Perugia, Italy, 06100
Mexico
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Guadalajara, Mexico, 44340
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Mexico City, Mexico, 06726
Puerto Rico
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Toa Baja, Puerto Rico, 00950
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:
No publications provided by Eli Lilly and Company

Additional 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
Study First Received: July 21, 2006
Last Updated: February 6, 2009
Health Authority: United States: Food and Drug Administration

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
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014