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

A Study for Patients With Type 1 Diabetes Mellitus

Sponsors

Lead sponsor: Eli Lilly and Company

Collaborator: Alkermes, Inc.

Source Eli Lilly and Company
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.

Overall Status Completed
Start Date April 2007
Completion Date May 2008
Primary Completion Date May 2008
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in HbA1c from baseline 12 and 24 weeks
Secondary Outcome
Measure Time Frame
Proportion of patients who achieve an HbA1c < 7% and <= 6.5% 12 and 24 weeks
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses at each visit
8-point self monitoring blood glucose profiles 12 and 24 weeks
Two hour glucose excursions for the morning, midday, and evening meals 12 and 24 weeks
Inhaler reliability throughout the study
Patient-reported treatment satisfaction and insulin delivery satisfaction 12 and 24 weeks
Preference for the study therapies week 24
Enrollment 70
Condition
Intervention

Intervention type: Drug

Intervention name: Insulin glargine

Description: Patient specific, injected, daily, 24 weeks

Intervention type: Drug

Intervention name: Human Insulin Inhalation Powder

Description: patient specific dose, inhaled, before meals,12 weeks

Other name: LY041001

Intervention type: Drug

Intervention name: Injectable Insulin

Description: Patient specific dose,injected, before meals, 12 weeks

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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
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) Study Director Eli Lilly and Company
Location
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. | Kanagawa, 235-0045, 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, 160-0023, 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. | Changhua, 500, 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, 104, 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, 333, Taiwan
Location Countries

Japan

Taiwan

Verification Date

October 2010

Responsible Party

Name title: Chief Medical Officer

Organization: Eli Lilly

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: 1

Arm group type: Experimental

Arm group label: 2

Arm group type: Experimental

Study Design Info

Allocation: Randomized

Intervention model: Crossover Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov