Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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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Please refer to this study by its ClinicalTrials.gov identifier: NCT00325364
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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 | |
| 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. | |
| 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 | |
| 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. | |
| Changhua, Taiwan, 500 | |
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| Neihu Taipei, Taiwan, 114 | |
| 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. | |
| 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 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases |
Insulin Insulin, Globin Zinc Hypoglycemic Agents Pharmacologic Actions Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on February 27, 2015