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

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00063128
First received: June 20, 2003
Last updated: December 20, 2007
Last verified: December 2007
  Purpose

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 Intervention Phase
Diabetes Mellitus, Type 1
Drug: insulin
Drug: human insulin inhalation powder (HIIP)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome 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 Outcome 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

Enrollment: 119
Study Start Date: April 2003
Study Completion Date: April 2004
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00063128

  Show 25 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Alkermes
Investigators
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
  More Information

Additional Information:
No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00063128     History of Changes
Other Study ID Numbers: 6944, H7U-MC-IDAI
Study First Received: June 20, 2003
Last Updated: December 20, 2007
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 29, 2014