Diabetes Mellitus, Type 1
Conditions
Brief summary
This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.
Interventions
patient specific dose, inhaled, before meals, 24 months, up to 36 months
patient specific dose, injectable, before meals, 24 months, up to 36 months.
DRUGInsulin Glargine
patient specific dose, injectable, as needed, 24 months up to 36 months
Sponsors
Alkermes, Inc.
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes * Non smoker * Normal lung function
Exclusion criteria
* Significant pulmonary, hepatic, or renal disease * Severe congestive heart failure * Active malignancy * Systemic glucocorticoid therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients. | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to glycemic control as assessed by the 8-point self-monitored blood glucose profiles | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by insulin antibody binding levels, adverse events, and episodes of hypoglycemia | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety using serial HRCT scans of the chest | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to safety as assessed by Six-Minute Walk Test with the Borg CR10 scale to access perceived exertion. | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to proportion of patients who achieve or maintain an HbA1c < 7.0 %. | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to FEV1, FVC, and total lung capacity (TLC), and diffusing capacity of the lung for carbon monoxide (DLCO). | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to Patient reported questionnaires. | 24 months |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization | 24 months |
| To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder. | throughout the study |
| To explore differences in cough and other pulmonary symptoms in patients treated with Human Insulin Inhalation Powder or preprandial injectable insulin using the Pulmonary Symptom Questionnaire. | months 32, 38, 40 and ED visits |
| To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to insulin dose requirements ( total, preprandial, and basal insulin) | 24 months |
Countries
Belgium, Canada, Croatia, Hungary, India, United States
Outcome results
None listed