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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00157339
First Posted: September 12, 2005
Last Update Posted: November 22, 2016
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 (Responsible Party):
Eli Lilly and Company
  Purpose
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.

Condition Intervention Phase
Diabetes Mellitus Asthma Pulmonary Disease, Chronic Obstructive Drug: Human Insulin Inhalation Powder Drug: injected insulin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c. [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin) [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status. [ Time Frame: 12 months ]
  • To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ]
  • To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ]
  • To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients. [ Time Frame: 12 months ]

Enrollment: 299
Study Start Date: August 2005
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, 12 months
Other Name: LY041001
Active Comparator: 2 Drug: injected insulin
patient specific dose, injected, before meals, 12 months.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • asthma or COPD

Exclusion Criteria:

  • Current smoking habit
  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): NCT00157339


  Hide Study Locations
Locations
United States, Alabama
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Montgomery, Alabama, United States, 36106
United States, California
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Burbank, California, United States, 91505
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Greenbrae, California, United States, 94904
United States, Connecticut
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Notwich, Connecticut, United States, 06360
United States, Florida
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Clearwater, Florida, United States, 33756
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Hollywood, Florida, United States, 33021
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Jacksonville, Florida, United States, 32204
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New Port Richey, Florida, United States, 34652
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Ocala, Florida, United States, 34471
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West Palm Beach, Florida, United States, 33401
United States, Illinois
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Belvidere, Illinois, United States, 61008
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Chicago, Illinois, United States, 60631
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Springfield, Illinois, United States, 62704
United States, Kansas
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Topeka, Kansas, United States, 66606
United States, Kentucky
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Louisville, Kentucky, United States, 40213
United States, Maryland
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Baltimore, Maryland, United States, 21204
United States, Massachusetts
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Brockton, Massachusetts, United States, 02301
United States, Nebraska
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Omaha, Nebraska, United States, 68131
United States, Nevada
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Las Vegas, Nevada, United States, 89146
United States, North Carolina
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Charlotte, North Carolina, United States, 28204
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Morehead City, North Carolina, United States, 28557
United States, Ohio
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Kettering, Ohio, United States, 45429
United States, Oregon
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Medford, Oregon, United States, 97504
United States, Pennsylvania
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Downingtown, Pennsylvania, United States, 19335
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Levittown, Pennsylvania, United States, 19056
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Sellersville, Pennsylvania, United States, 18960
United States, South Carolina
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Simpsonville, South Carolina, United States, 29681
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Spartanburg, South Carolina, United States, 29303
United States, South Dakota
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Sioux Falls, South Dakota, United States, 57105
United States, Texas
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El Paso, Texas, United States, 79902
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Houston, Texas, United States, 77090
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Humble, Texas, United States, 77338
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Midland, Texas, United States, 79705
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San Antonio, Texas, United States, 78229
United States, Virginia
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Norfolk, Virginia, United States, 23502
United States, Washington
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Tacoma, Washington, United States, 98405
Argentina
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Buenos Aires, Argentina, C1181ACH
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Cordoba, Argentina, 5000
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Mendoza, Argentina, 5500
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Ramos Mejia, Argentina, B1704ETD
Bulgaria
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Haskovo, Bulgaria, 6300
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Pazardzhik, Bulgaria, 4400
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4003
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Sofia, Bulgaria, 1606
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Stara Zagora, Bulgaria, 6003
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Newfoundland and Labrador
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St Johns, Newfoundland and Labrador, Canada, A1B 3V6
Canada, Ontario
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Corunna, Ontario, Canada, N0N 1G0
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Niagara Falls, Ontario, Canada, L2G1J4
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Sarnia, Ontario, Canada, N7T 4X3
Canada, Quebec
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Longueuil, Quebec, Canada, J4N 1E1
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Sainte-Foy, Quebec, Canada, G1V 4G2
Chile
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San Miguel, Chile, S/N
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Vina Del Mar, Chile, 2570017
Colombia
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Bogota, Colombia
Croatia
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Zagreb, Croatia, HR-10000
Hong Kong
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Kwun Tong, Hong Kong
Hungary
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Budapest, Hungary, 1076
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Eger, Hungary, 3300
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Gyula, Hungary, 5701
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Kalocsa, Hungary, 6300
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Kecskemet, Hungary, 6000
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Nyiregyhaza, Hungary, H-4400
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Szekesfehervar, Hungary, 8000
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Szolnok, Hungary, 5000
India
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Ahmedabad, India, 38009
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Bangalore, India, 560017
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Chennai, India, 600010
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Cochin, India, 682026
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Coimbatore, India, 643209
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Gandhinagar, India, 382428
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Hyderabaad, India, 500033
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Kolkatta, India, 700054
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Kormangala, India, 560034
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Mangalore, India, 575001
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Mumbai, India, 400016
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Nagpur, India, 440012
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New Delhi, India, 110057
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Noida, India, 201301
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P.O Ernakulam, India, 682304
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Porur, India, 600116
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Pune, India, 411011
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Secunderabad, India, 800003
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Tamil Nadu, India, 600 006
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Vellore, India, 632 004
Mexico
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Mexico City, Mexico, 11650
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Monterrey, Mexico, 64460
Philippines
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Barangay Pembo, Philippines, 1218
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Dillman, Philippines
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Ermita, Philippines
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Espana, Philippines
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Manila, Philippines, 1007
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Pasig City, Philippines
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Quezon City, Philippines, 1102
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San Juan, Philippines
Puerto Rico
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Ponce, Puerto Rico, 00732
Singapore
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Singapore, Singapore, 159964
Taiwan
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Taichung, Taiwan, 407
Thailand
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Bangkoknoi, Thailand, 10700
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Bangkok, Thailand, 10330
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 to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) Eli Lilly and Company
  More Information

Additional Information:
Publications:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00157339     History of Changes
Other Study ID Numbers: 7091
H7U-MC-IDAS ( Other Identifier: Eli Lilly and Company )
First Submitted: September 7, 2005
First Posted: September 12, 2005
Last Update Posted: November 22, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.


Additional relevant MeSH terms:
Diabetes Mellitus
Asthma
Lung Diseases
Chronic Disease
Pulmonary Disease, Chronic Obstructive
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Disease Attributes
Pathologic Processes
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs