A Study for Patients With Type 1 Diabetes Mellitus

NCT00447213 | Completed Phase 2

• 2 other identifiers: 10299H7U-JE-IDBB
• Study Type: interventional
• Target: 70
• Locations: 2 countries
• Sites: 5

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.

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c from baseline

  12 and 24 weeks

Secondary Outcomes (7)

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: Insulin glargine; Drug: Human Insulin Inhalation Powder; Drug: Injectable Insulin

2

EXPERIMENTAL

Drug: Insulin glargine; Drug: Human Insulin Inhalation Powder; Drug: Injectable Insulin

Interventions

Insulin glargine DRUG

Patient specific, injected, daily, 24 weeks

1; 2

Human Insulin Inhalation Powder DRUG

patient specific dose, inhaled, before meals,12 weeks

Also known as: LY041001

1; 2

Injectable Insulin DRUG

Patient specific dose,injected, before meals, 12 weeks

1; 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Alkermes, Inc.: collaborator

Study Sites (5)

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

Location

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

Location

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

Location

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

Location

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.

Taoyuan District, 333, Taiwan

Location

Related 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.

  RESULT

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 14, 2007
• Study Start: April 1, 2007
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: October 13, 2010

Record last verified: 2010-10

Locations

JP (2); TW (3)