Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00063128
Recruitment Status : Completed
First Posted : June 25, 2003
Last Update Posted : December 21, 2007
Alkermes, Inc.
Information provided by:
Eli Lilly and Company

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Drug: insulin Drug: human insulin inhalation powder (HIIP) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus
Study Start Date : April 2003
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A 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.
Other Name: LY041001
Active Comparator: B 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
Other Name: LY041001

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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
  2. 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
  3. assess the safety of HIIP using pulmonary function tests, chest x rays, insulin antibody titers, adverse events (AEs), and episodes of hypoglycemia
  4. assess symptoms of diabetes, patient vitality, and patient satisfaction with the diabetes treatments
  5. 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
  6. assess insulin inhaler reliability
  7. assess patient compliance with the HIIP delivery system Directions for Use (DFU)
  8. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT00063128

  Show 25 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes, Inc.
Study Director: 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) Eli Lilly and Company

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly Identifier: NCT00063128     History of Changes
Other Study ID Numbers: 6944
First Posted: June 25, 2003    Key Record Dates
Last Update Posted: December 21, 2007
Last Verified: December 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs