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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00325364
First received: May 10, 2006
Last updated: July 3, 2008
Last verified: July 2008
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 2
Drug: Human Insulin Inhalation Powder
Drug: Injectable insulin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/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 and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to change on body weight [ Time Frame: baseline and every visit ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To test dose titration methods [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • To assess inhaler reliability [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
  • To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients [ Time Frame: 3 months, 6 months ] [ Designated as safety issue: No ]

Enrollment: 415
Study Start Date: April 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, 24 months
Other Name: LY041001
Active Comparator: 2 Drug: Injectable insulin
patient specific dose, injectable, before meals, 24 months

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00325364

  Hide Study Locations
Locations
United States, California
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.
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
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

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00325364     History of Changes
Other Study ID Numbers: 9626, H7U-MC-IDAU
Study First Received: May 10, 2006
Last Updated: July 3, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 17, 2014