Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DRUGinsulin
* Administer subcutaneous regular human insulin 30 to 60 minutes before meals, or administer insulin lispro within 15 minutes before meals. * Inject into abdomen only.
DRUGhuman 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
Sponsors
Alkermes, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 12 weeks per therapy |
Secondary
| Measure | Time frame |
|---|---|
| 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 the pharmacokinetics of test doses of preprandial HIIP and preprandial injectable insulin (regular human insulin or insulin lispro) administered to a subgroup of patients | — |
| 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 | — |
| 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 | — |
Countries
United States
Outcome results
None listed