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Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00127634
First Posted: August 8, 2005
Last Update Posted: August 8, 2008
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:
Eli Lilly and Company
  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 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Long-Term, Open-Label, Parallel Study of the Efficacy and Safety of Human Insulin Inhalation Powder 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 assess change in baseline to endpoint in HbA1c in type 1 diabetic patients. [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO). [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion. [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %. [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin) [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires. [ Time Frame: 24 months ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization [ Time Frame: 24 months ]
  • To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ]
  • To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire. [ Time Frame: months 32, 38, 40 and ED visits ]
  • To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles [ Time Frame: 24 months ]

Enrollment: 385
Study Start Date: July 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, 24 months, up to 36 months
Other Name: LY041001
Drug: Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
Active Comparator: 2 Drug: Injectable Insulin
patient specific dose, injectable, before meals, 24 months, up to 36 months.
Drug: Insulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months

  Eligibility

Information from the National Library of Medicine

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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 1 diabetes
  • Non smoker
  • Normal lung function

Exclusion Criteria:

  • Significant pulmonary, hepatic, or renal disease
  • Severe congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy
  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): NCT00127634


  Hide Study Locations
Locations
United States, California
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Sacramento, California, United States
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Walnut Creek, California, United States
United States, Colorado
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Aurora, Colorado, United States
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Denver, Colorado, United States
United States, Delaware
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Newark, Delaware, United States
United States, Florida
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Hollywood, Florida, United States
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Jacksonville, Florida, United States, 32204
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Largo, Florida, United States
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New Port Richey, Florida, United States
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West Palm Beach, Florida, United States
United States, Georgia
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Atlanta, Georgia, United States
United States, Idaho
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Idaho Falls, Idaho, United States
United States, Illinois
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Chicago, Illinois, United States
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Springfield, Illinois, United States
United States, Indiana
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Indianapolis, Indiana, United States
United States, Kentucky
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Louisville, Kentucky, United States
United States, Maryland
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Baltimore, Maryland, United States
United States, Missouri
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St. Louis, Missouri, United States
United States, Nebraska
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Omaha, Nebraska, United States
United States, New Jersey
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North Plainfield, New Jersey, United States, 07060
United States, New York
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Flushing, New York, United States, 11365
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Lake Success, New York, United States
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New Hyde Park, New York, United States
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Staten Island, New York, United States
United States, North Carolina
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Morehead City, North Carolina, United States, 28557
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Raleigh, North Carolina, United States
United States, Oregon
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Medford, Oregon, United States
United States, Pennsylvania
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Downingtown, Pennsylvania, United States
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Sellersville, Pennsylvania, United States, 34652
United States, South Dakota
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Sioux Falls, South Dakota, United States
United States, Texas
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
United States, Washington
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Renton, Washington, United States, 98055
United States, Wisconsin
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Milwaukee, Wisconsin, United States, 53209
Belgium
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Aalst, Belgium
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Arlon, Belgium
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Brussels, Belgium
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Edegem, Belgium
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Leuven, Belgium
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Liege, Belgium
Canada, Manitoba
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Winnipeg, Manitoba, Canada
Canada, Ontario
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Corunna, Ontario, Canada
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Niagara Falls, Ontario, Canada
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Peterborough, Ontario, Canada
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Sarnia, Ontario, Canada
Canada, Quebec
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Montreal, Quebec, Canada
Croatia
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Zagreb, Croatia
Hungary
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Budapest, Hungary
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Debrecen, Hungary
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Eger, Hungary
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Gyula, Hungary
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Kecskemet, Hungary
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Nyiregyhaza, Hungary
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Szeged, Hungary
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Szolnok, Hungary
India
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Bangalore, India
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Kochin, India
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Mumbai, India
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New Dehli, India
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Noida, India
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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00127634     History of Changes
Other Study ID Numbers: 6120
H7U-MC-IDAH
First Submitted: August 4, 2005
First Posted: August 8, 2005
Last Update Posted: August 8, 2008
Last Verified: August 2008

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
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs