Clinical trial NCT00447213: A Study for Patients With Type 1 Diabetes Mellitus
Official title: A Crossover Study to Evaluate the Efficacy and Safety of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Alkermes, Inc.
First posted: 2007-03-14
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the human insulin inhalation powder plus insulin glargine with injected insulin (regular human insulin or insulin lispro) plus insulin glargine on lowering the blood sugar level.


Eligibility criteria: Inclusion Criteria:

* Type 1 diabetes mellitus for at least 24 months
* Injecting insulin (insulin lispro, aspart or regular insulin, insulin lispro/aspart mixtures, or regular human insulin mixtures) in the last 24 months
* HbA1c equal or less than 11 %
* Nonsmokers, had not smoked for at least 6 months and agree not to smoke (cigars, cigarettes or pipes) or use smokeless tobacco for the duration of the study
* Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria:

* Previously received any form of inhaled insulin
* Require a daily total insulin dosage greater than 100 U
* Have a current or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
* History or presence of liver disease
* History or presence of kidney disease

Primary outcomes:
measure: Change in HbA1c from baseline
timeFrame: 12 and 24 weeks
Secondary outcomes:
measure: Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
timeFrame: 12 and 24 weeks
measure: Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
timeFrame: at each visit
measure: 8-point self monitoring blood glucose profiles
timeFrame: 12 and 24 weeks
measure: Two hour glucose excursions for the morning, midday, and evening meals
timeFrame: 12 and 24 weeks
measure: Inhaler reliability
timeFrame: throughout the study
measure: Patient-reported treatment satisfaction and insulin delivery satisfaction
timeFrame: 12 and 24 weeks
measure: Preference for the study therapies
timeFrame: week 24
Other outcomes:
Locations:
city: Kanagawa
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
city: Changhua
country: Taiwan
facility: 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.
city: Taipei
country: Taiwan
facility: 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.
city: Tao-Yuan
country: Taiwan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-277-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Hitoshi Ishii, Satoru Tsujii, Masami Tanaka, Miyuki Furuya, Tadao Iburi, Rei Ueda, Sakura Okuyama, Risa P. Hayes, Masato Okamura, Kazuya Iwamoto, Eisei Oda. Development of IDSQ-J and assessment of reproducibility adequacy. Tonyobyo. 2009;52(3):209-221.