Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

Phase 3

Completed

Conditions: Diabetes Mellitus, Type 1

Interventions: Drug: Human Insulin Inhalation Powder
Drug: Injectable Insulin
Drug: Insulin Glargine

Registration Number: NCT00127634

Lead Sponsor: Eli Lilly and Company

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 385

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Human Insulin Inhalation Powder	-
1	Insulin Glargine	-
2	Injectable Insulin	-
2	Insulin Glargine	-

Primary Outcome Measures

Name	Time	Method
To assess change in baseline to endpoint in HbA1c in type 1 diabetic patients.	24 months

Secondary Outcome Measures

Name	Time	Method
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 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 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 safety using serial HRCT scans of the chest	24 months
To assess inhaler reliability in patients randomized to treatment with Human Insulin Inhalation Powder.	throughout the study
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 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 insulin dose requirements ( total, preprandial, and basal insulin)	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 resource utilization	24 months
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

Trial Locations

Locations (2): For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1877-285-4559, 1-317-615-4559) Mon-Fri from 9AM to 5PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
🇮🇳
Noida, India
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 hrs, EST), or speak with your personal physician.
🇭🇺
Szeged, Hungary