A Study for Patients With Type 1 Diabetes Mellitus - Full Text View

Sponsors and Collaborators:	Eli Lilly and Company Alkermes
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00447213

Purpose

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.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: Insulin glargine Drug: Human Insulin Inhalation Powder Drug: Injectable Insulin	Phase II Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
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

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Change in HbA1c from baseline [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Proportion of patients who achieve an HbA1c < 7% and <= 6.5% [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses [ Time Frame: at each visit ] [ Designated as safety issue: No ]
8-point self monitoring blood glucose profiles [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Two hour glucose excursions for the morning, midday, and evening meals [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Inhaler reliability [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Patient-reported treatment satisfaction and insulin delivery satisfaction [ Time Frame: 12 and 24 weeks ] [ Designated as safety issue: No ]
Preference for the study therapies [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Enrollment:	70
Study Start Date:	April 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Insulin glargine Patient specific, injected, daily, 24 weeks Drug: Human Insulin Inhalation Powder patient specific dose, inhaled, before meals,12 weeks Drug: Injectable Insulin Patient specific dose,injected, before meals, 12 weeks
2: Experimental	Drug: Insulin glargine Patient specific, injected, daily, 24 weeks Drug: Human Insulin Inhalation Powder patient specific dose, inhaled, before meals,12 weeks Drug: Injectable Insulin Patient specific dose,injected, before meals, 12 weeks

Eligibility

Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00447213

Locations

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, Japan, 160-0023
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, 235-0045
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, 500
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, 104
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, Taiwan, 333

Sponsors and Collaborators

Eli Lilly and Company

Alkermes

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	10299, H7U-JE-IDBB
Study First Received:	March 12, 2007
Last Updated:	July 3, 2008
ClinicalTrials.gov Identifier:	NCT00447213
Health Authority:	Japan: Ministry of Health, Labor and Welfare; Taiwan: Department of Health

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
Diabetes Mellitus

Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009