Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD
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| ClinicalTrials.gov Identifier: NCT00157339 |
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Recruitment Status :
Completed
First Posted : September 12, 2005
Last Update Posted : March 9, 2018
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Sponsor:
Eli Lilly and Company
Collaborator:
Alkermes, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
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Brief Summary:
Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Asthma Pulmonary Disease, Chronic Obstructive | Drug: Human Insulin Inhalation Powder Drug: injected insulin | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 299 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pivotal, Open-Label, Parallel Study to Evaluate the Safety and Efficacy of Human Insulin Inhalation Powder (HIIP) Compared to Injectable Insulin in Patients With Diabetes and COPD or Asthma |
| Study Start Date : | August 2005 |
| 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, 12 months
Other Name: LY041001 |
| Active Comparator: 2 |
Drug: injected insulin
patient specific dose, injected, before meals, 12 months. |
Primary Outcome Measures :
- To test the hypothesis that the glycemic control achieved with preprandial Human Insulin Inhalation Powder is noninferior to that achieved with injectable insulin, as measured by mean change from baseline to endpoint in HbA1c. [ Time Frame: 12 months ]
Secondary Outcome Measures :
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on FEV1 and FVC before and after inhalation of bronchodilator. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on the response to bronchodilator as measured by change between pre- and post- bronchodilator FEV1 and FVC [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by insulin antibody levels, adverse events, and episodes of hypoglycemia [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by chest x-rays. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the St. George's Respiratory Questionnaire. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on safety as assessed by the Six-Minute Walk Test with the Borg CR10 Scale. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on proportion of patients who achieve or maintain HbA1c of less than or equal to 6.5% and who achieve or maintain HbA1c of < 7 %. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and inj. insulin on proportion of pts with type 2 on oral agent(s) rand. to Human Insulin Inhalation Powder only or glargine only who do not reach an HbA1c <7.5 % after six months. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on glycemic control as assessed by the 8-point-self monitored blood glucose profiles [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on insulin dose requirements ( including total, basal, and/or bolus insulin) [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on patient-reported outcomes questionnaires to assess general health status. [ Time Frame: 12 months ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ]
- To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ]
- To explore the impact of Human Insulin Inhalation Powder on peak flow and peak flow variability in the study with asthma patients. [ Time Frame: 12 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type 1 or type 2 diabetes
- asthma or COPD
Exclusion Criteria:
- Current smoking habit
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): NCT00157339
Show 101 Study Locations
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 to 5 PM Eastern Time (UTC/GMT - 5 hour, EST) | Eli Lilly and Company |
Additional Information:
Publications of Results:
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT00157339 History of Changes |
| Other Study ID Numbers: |
7091 H7U-MC-IDAS ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | September 12, 2005 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:
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Diabetes Mellitus Asthma Lung Diseases Chronic Disease Pulmonary Disease, Chronic Obstructive Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Disease Attributes Pathologic Processes Insulin, Globin Zinc Insulin Hypoglycemic Agents Physiological Effects of Drugs |