Official Title: “A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus”

The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

Intervention(s) in this Clinical Trial

• Drug: Insulin glargine
  • Patient specific, injected, daily, 24 weeks
• Drug: Human Insulin Inhalation Powder
  • patient specific dose, inhaled, before meals,12 weeks
• Drug: Injectable Insulin
  • Patient specific dose,injected, before meals, 12 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2

Primary Measures

• Change in HbA1c from baseline
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No

Secondary Measures

• Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No
• Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
  • Time Frame: at each visit
    Safety Issue?: No
• 8-point self monitoring blood glucose profiles
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No
• Two hour glucose excursions for the morning, midday, and evening meals
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No
• Inhaler reliability
  • Time Frame: throughout the study
    Safety Issue?: No
• Patient-reported treatment satisfaction and insulin delivery satisfaction
  • Time Frame: 12 and 24 weeks
    Safety Issue?: No
• Preference for the study therapies
  • Time Frame: week 24
    Safety Issue?: No

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 24 months
• Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
• HbA1c equal or less than 11 %
• Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
• Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria:

• Previously received any form of inhaled insulin
• Require a daily total insulin dosage greater than 100 U
• Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
• History or presence of liver disease
• History or presence of kidney disease

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Eli Lilly and Company

Overall Clinical Trial Officials and Contacts

Call 1-877-CTLILLY (1-277-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Study Director Eli Lilly and Company  

Information obtained from ClinicalTrials.gov on September 05, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00447213

Study ID Number: 10299

ClinicalTrials.gov Identifier: NCT00447213

Health Authority: Japan: Ministry of Health, Labor and Welfare

Lilly Clinical Trial Registry