A Phase 3 interventional study of Human Insulin Inhalation Powder and Injectable Insulin in Diabetes Mellitus, Type 1, sponsored by Eli Lilly and Company. Completed at 61 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-09.
Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 385 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.
Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Human Insulin Inhalation Powder · Drug: Insulin Glargine
Drug: Injectable Insulin · Drug: Insulin Glargine
patient specific dose, inhaled, before meals, 24 months, up to 36 months
Also known as: LY041001
patient specific dose, injectable, before meals, 24 months, up to 36 months.
patient specific dose, injectable, as needed, 24 months up to 36 months
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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 %.
Time frame: 24 months
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)
Time frame: 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.
Time frame: 24 months
To compare preprandial Human Insulin Inhalation Powder with preprandial injectable insulin in patients with type 1 diabetes with respect to resource utilization
Time frame: 24 months
To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.
Time frame: 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.
Time frame: 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 glycemic control as assessed by the 8-point self-monitored blood glucose profiles
Time frame: 24 months
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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Eli Lilly and Company