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Completed

NCT Number: NCT00063128

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician., San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Insulin

Drug
  • 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 names: LY041001

human insulin inhalation powder (HIIP)

Drug
  • 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 names: LY041001

Primary outcomes

  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 outcomes

  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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Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Collaborators

  • Alkermes, Inc.

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Jun 25, 2003
Registry last updated
Dec 21, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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