A Study for Patients With Type 1 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00447213
First received: March 12, 2007
Last updated: October 12, 2010
Last verified: October 2010
  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 2
Phase 3

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

Resource links provided by NLM:


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
Experimental: 1 Drug: Insulin glargine
Patient specific, injected, daily, 24 weeks
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
Other Name: LY041001
Drug: Injectable Insulin
Patient specific dose,injected, before meals, 12 weeks
Experimental: 2 Drug: Insulin glargine
Patient specific, injected, daily, 24 weeks
Drug: Human Insulin Inhalation Powder
patient specific dose, inhaled, before meals,12 weeks
Other Name: LY041001
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.
Kanagawa, Japan, 235-0045
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
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

Additional Information:
Publications:
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.

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00447213     History of Changes
Other Study ID Numbers: 10299, H7U-JE-IDBB
Study First Received: March 12, 2007
Last Updated: October 12, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare
Taiwan: Department of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glargine
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 22, 2014