A Study for Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Collaborator:
Alkermes
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00490854
First received: June 21, 2007
Last updated: July 3, 2008
Last verified: July 2008
  Purpose

The purpose of the study is to compare the human insulin inhalation powder plus oral anti-hyperglycemic medication with injected insulin (neutral protamine hegedom insulin) plus oral anti-hyperglycemic medication on lowering the blood sugar level.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Human Insulin Inhalation Powder
Drug: Neutral protamine hagedorn 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 Once-Daily NPH in Insulin-Naïve Patients With Type 2 Diabetes Mellitus on Oral Agents

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • Mean change in Hemoglobin A1c (HbA1c) from baseline to the end of each treatment period of Primary Phase [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 8-point SMBG profiles. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
  • Mean change in HbA1c from baseline to the end. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
  • Mean dosage of both preprandial and basal insulin. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
  • Inhaler reliability. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]
  • Patient-reported outcomes questionnaires. [ Time Frame: 24, 48 and 76 weeks after Randomization ] [ Designated as safety issue: No ]

Enrollment: 129
Study Start Date: July 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: Human Insulin Inhalation Powder
patient specific, inhaled, at meals, 76 weeks
Other Name: LY 041001
Drug: Neutral protamine hagedorn insulin
patient specific dose, injected, daily, 76 weeks
Experimental: 2 Drug: Human Insulin Inhalation Powder
patient specific, inhaled, at meals, 76 weeks
Other Name: LY 041001
Drug: Neutral protamine hagedorn insulin
patient specific dose, injected, daily, 76 weeks

  Eligibility

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

Inclusion Criteria:

  1. Type 2 diabetes mellitus for at least 6 months
  2. One or more oral antihyperglycemic medications for at least 12 weeks
  3. HbA1c equal to or greater than 7.0%, and equal to or less than 10.5%
  4. Nonsmokers, have 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
  5. Satisfactory lung function results to meet the requirement of the study

Exclusion Criteria:

  1. Previously received any form of inhaled insulin
  2. Have a current diagnosis or past history of asthma, chronic obstructive pulmonary disease or other clinically relevant lung disease
  3. History or presence of liver disease
  4. 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: NCT00490854

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.
Aichi, Japan, 451-8511
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.
Chiba, Japan, 2892511
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.
Fukuoka, Japan, 830-8543
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.
Fukushima, Japan, 963-8851
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.
Gunma, Japan, 370-2393
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.
Hokkaido, Japan, 060-8648
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.
Hyogo, Japan, 663-8501
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.
Nara, Japan, 632-8552
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.
Osaka, Japan, 569-1096
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.
Shiga, Japan, 520-2192
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, 150-8935
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.
Toyama, Japan, 930-8550
Sponsors and Collaborators
Eli Lilly and Company
Alkermes
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
  More Information

Additional Information:
No publications provided

Responsible Party: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00490854     History of Changes
Other Study ID Numbers: 10513, H7U-JE-IDBF
Study First Received: June 21, 2007
Last Updated: July 3, 2008
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, NPH
Protamines
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Heparin Antagonists
Molecular Mechanisms of Pharmacological Action
Coagulants
Hematologic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014