Official Title: “Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus”

This is a research study of a study drug known as LY041001 or human insulin inhalation powder (HIIP). HIIP is a powder form of insulin made to be inhaled through the mouth and into the lungs using a special handheld device.

Study Type: Interventional

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

Intervention(s) in this Clinical Trial

• Drug: insulin
  • Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals. Inject into abdomen only.
• Drug: human insulin inhalation powder (HIIP)
  • Administer HIIP within 15 minutes before meals. Administer doses in one-capsule increments equivalent to approximately 2 IU or 6 IU of subcutaneous insulin. Target treatment goals during the treatment sequence are the same as for patients using preprandial injectable insulin

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
• Active Comparator: B

Primary Measures

• test the hypothesis that preprandial HIIP plus insulin glargine is noninferior to preprandial injectable insulin (regular human insulin or insulin lispro) plus insulin glargine with respect to HbA1c
  • Time Frame: 12 weeks per therapy
    

Secondary Measures

• compare the pharmacokinetics of test doses of preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro) administered to a subgroup of patients
• compare 7-point self-monitored blood glucose profiles (blood glucose measurements before & 2 hours after start of morning, midday, evening meals, and blood glucose measurement at bedtime) for preprandial HIIP and preprandial inject
• assess the safety of HIIP using pulmonary function tests, chest x rays, insulin antibody titers, adverse events (AEs), and episodes of hypoglycemia
• assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments
• compare insulin dose requirements (both preprandial and basal insulin [insulin glargine]) of patients administering preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro
• assess insulin inhaler reliability
• assess patient compliance with the HIIP delivery system Directions for Use (DFU)
• assess the impact of practice inhalations on inspiratory flow parameters (peak inspiratory flow rate [IFR] and total inspired volume [TIV]) achieved by patients using the insulin inhaler following training with the DFU

Inclusion Criteria:

• You are at least 18 years old.
• You have had type 1 diabetes for at least 2 years.
• You are injecting insulin lispro (Humalog), an insulin lispro mixture (Humalog
• Mixture), regular human insulin mixture (Humulin mixture) before meals using a syringe or injection pen, not an insulin pump.
• If you are female and could become pregnant, you test negative for pregnancy based on blood test at the beginning of the study, do not intend to become pregnant, and agree to use a form of birth control approved by the investigator during the study.
• You have not smoked for at least 1 year, and you agree not to smoke or use smokeless tobacco during the study.

Exclusion Criteria:

• You have used an experimental drug during the last 30 days or have ever taken part in a study of any type of inhaled insulin.
• You have a history of asthma or allergies.
• You have a chronic cough.
• You have had a kidney transplant, are on dialysis, or have poor kidney function.
• You have a history of chest pain, heart attack, or you have a heart condition that limits your physical activity due to discomfort.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 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 (1-877-285-4559) 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 November 19, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00063128

Study ID Number: 6944

ClinicalTrials.gov Identifier: NCT00063128

Health Authority: United States: Food and Drug Administration

Lilly Clinical Trial Registry