Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Study Description

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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 Design

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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

Arms and Interventions

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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.

Outcome Measures

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Primary Outcome Measures :

1. 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 :

1. 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 ]
2. 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 ]
3. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ]
4. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ]
5. 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 ]
6. 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 ]
7. 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 ]
8. 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 ]
9. 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 ]
10. 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 ]
11. 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 ]
12. 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 ]
13. 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 ]
14. To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ]
15. To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ]
16. 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 ]

Eligibility Criteria

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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 or type 2 diabetes
• asthma or COPD

Exclusion Criteria:

• Current smoking habit

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

  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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Lilly CSR Synopsis 

Publications of Results:

Ang E, Lawrence MK, Heilmann CR, Ferguson JA, Tobian JA, Webb DM, Berclaz PY. Safety and efficacy of AIR inhaled insulin compared with subcutaneous insulin in patients having diabetes and asthma: A 12-month, randomized, noninferiority trial. Diabetes Technol Ther. 2009 Sep;11 Suppl 2:S35-44. doi: 10.1089/dia.2009.0054.

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
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; 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