A Study for Patients With Type 1 Diabetes Mellitus

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447213
• Other study ID #: 10299
• Secondary ID: H7U-JE-IDBB
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: March 12, 2007
• Last updated: October 12, 2010
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: October 2010
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and WelfareTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• Insulin glargine
Patient specific, injected, daily, 24 weeks
• Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
• Injectable Insulin
Patient specific dose,injected, before meals, 12 weeks

Locations

Country	Name	City	State
Japan	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.	Kanagawa
Japan	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.	Tokyo
Taiwan	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.	Changhua
Taiwan	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.	Taipei
Taiwan	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.	Tao-Yuan

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	Alkermes, Inc.

Countries where clinical trial is conducted

Japan,  Taiwan, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from baseline		12 and 24 weeks	No
Secondary	Proportion of patients who achieve an HbA1c < 7% and <= 6.5%		12 and 24 weeks	No
Secondary	Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses		at each visit	No
Secondary	8-point self monitoring blood glucose profiles		12 and 24 weeks	No
Secondary	Two hour glucose excursions for the morning, midday, and evening meals		12 and 24 weeks	No
Secondary	Inhaler reliability		throughout the study	No
Secondary	Patient-reported treatment satisfaction and insulin delivery satisfaction		12 and 24 weeks	No
Secondary	Preference for the study therapies		week 24	No

External Links

•   Lilly Clinical Trial Registry