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

This study has been completed.
Sponsor:
Collaborator:
Alkermes, Inc.
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
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: 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

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, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014