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

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
|
- 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 ]
- To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin [ Time Frame: 24 months ]
- To compare inhaled human insulin to injectable insulin over time with respect to change on body weight [ Time Frame: baseline and every visit ]
- 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 ]
- 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 ]
- 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 ]
- To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements [ Time Frame: 24 months ]
- To test dose titration methods [ Time Frame: 6 months ]
- To assess inhaler reliability [ Time Frame: throughout the study ]
- To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients [ Time Frame: 3 months, 6 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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

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 |
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 |
Additional Information:
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 |