September 7, 2005 |
July 3, 2008 |
August 2005 |
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 ] [ Designated as safety issue: No ] |
Same as current |
Complete list of historical versions of study NCT00157339 on ClinicalTrials.gov Archive Site |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on DLco. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on total lung capacity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- To compare the effects of preprandial Human Insulin Inhalation Powder and injectable insulin on resource utilization. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- To assess insulin inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
|
Same as current |
|
Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD |
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 |
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. |
|
Phase III |
Interventional |
Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
- Diabetes Mellitus
- Asthma
- Pulmonary Disease, Chronic Obstructive
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- Drug: Human Insulin Inhalation Powder
- Drug: injected insulin
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Completed |
299 |
May 2008 |
May 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Type 1 or type 2 diabetes
- asthma or COPD
Exclusion Criteria:
|
Both |
18 Years and older |
No |
|
United States, Argentina, Bulgaria, Canada, Chile, Colombia, Croatia, Hong Kong, Hungary, India, Mexico, Philippines, Puerto Rico, Singapore, Taiwan, Thailand |
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NCT00157339 |
Chief Medical Officer, Eli Lilly |
H7U-MC-IDAS |
Eli Lilly and Company |
Alkermes |
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 |
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Eli Lilly and Company |
July 2008 |