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Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT00325364
Recruitment Status : Completed
First Posted : May 12, 2006
Last Update Posted : March 9, 2018
Sponsor:
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief 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 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Human Insulin Inhalation Powder Drug: Injectable insulin Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 415 participants
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 and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.
Study Start Date : April 2006
Actual Primary Completion Date : May 2008
Actual Study Completion Date : May 2008

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals, 24 months
Other Name: LY041001
Active Comparator: 2 Drug: Injectable insulin
patient specific dose, injectable, before meals, 24 months


Outcome Measures
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Primary Outcome Measures :
  1. To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin [ Time Frame: 24 months ]
  2. To compare inhaled human insulin to injectable insulin over time with respect to change on body weight [ Time Frame: baseline and every visit ]
  3. To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction [ Time Frame: baseline, 6 months, 12 months, 18 months, 24 months ]
  4. To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c [ Time Frame: baseline and every visit ]
  5. To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia [ Time Frame: throughout the study ]
  6. To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements [ Time Frame: 24 months ]
  7. To test dose titration methods [ Time Frame: 6 months ]
  8. To assess inhaler reliability [ Time Frame: throughout the study ]
  9. To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients [ Time Frame: 3 months, 6 months ]

Eligibility Criteria
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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 2 diabetes
  • Non smoker
  • Normal lung function

Exclusion Criteria:

  • Pulmonary, hepatic, or renal disease
  • Congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy
Contacts and Locations
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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): NCT00325364


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Locations
United States, California
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Sacramento, California, United States, 95825
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Santa Ana, California, United States, 92705
United States, Florida
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Jacksonville, Florida, United States, 32204
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Miami, Florida, United States, 33156
United States, Louisiana
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Baton Rouge, Louisiana, United States, 70808
United States, New Jersey
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Hamilton, New Jersey, United States, 08610
United States, South Carolina
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Greenville, South Carolina, United States, 29605
United States, Utah
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Ogden, Utah, United States, 84403
United States, West Virginia
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Charleston, West Virginia, United States, 25304
Brazil
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Fortaleza, Brazil, 60120-020
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Porto Alegre, Brazil, 90035-003
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São Paulo, Brazil, 04020041
Germany
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Berlin, Germany, 10115
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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Frankfurt, Germany, 60596
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Leipzig, Germany, D-04103
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Mainz, Germany, D-55116
Hungary
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Budapest, Hungary, H-1139
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Mako, Hungary, 6900
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Veszprem, Hungary, 8200
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Zalaegerszeg, Hungary, 8900
India
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Bangalore, India, 560010
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Mumbai, India, 400 007
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Pune, India, 411005
Italy
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Catania, Italy, 95100
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Genova, Italy, 16132
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Milano, Italy, 20132
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Pisa, Italy, 56100
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Rome, Italy, 00168
Mexico
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Mexico City, Mexico, 06700
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Monterrey, Mexico, 64410
Poland
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Katowice, Poland, 40-044
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Lublin, Poland, 20-954
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Olesnica, Poland
Portugal
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Coimbra, Portugal, 3000-076
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Lisbon, Portugal, 1250-203
Puerto Rico
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Manatí, Puerto Rico, 00674
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San Juan, Puerto Rico, 00907
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Yabucoa, Puerto Rico, 00767
Taiwan
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Changhua, Taiwan, 500
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Neihu Taipei, Taiwan, 114
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Yungkang City, Taiwan, 710
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Lilly CSR Synopsis  This link exits the ClinicalTrials.gov site

Publications of Results:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT00325364     History of Changes
Other Study ID Numbers: 9626
H7U-MC-IDAU ( Other Identifier: Eli Lilly and Company )
First Posted: May 12, 2006    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
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
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs