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A Study for Patients With Type 1 Diabetes Mellitus

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Insulin glargine
Human Insulin Inhalation Powder
Injectable Insulin
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 1

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 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.
  • 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.
  • 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.
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c from baseline

Secondary Outcome Measures

Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
8-point self monitoring blood glucose profiles
Two hour glucose excursions for the morning, midday, and evening meals
Inhaler reliability
Patient-reported treatment satisfaction and insulin delivery satisfaction
Preference for the study therapies

Full Information

First Posted
March 12, 2007
Last Updated
October 12, 2010
Sponsor
Eli Lilly and Company
Collaborators
Alkermes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00447213
Brief Title
A Study for Patients With Type 1 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company
Collaborators
Alkermes, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Insulin glargine
Intervention Description
Patient specific, injected, daily, 24 weeks
Intervention Type
Drug
Intervention Name(s)
Human Insulin Inhalation Powder
Other Intervention Name(s)
LY041001
Intervention Description
patient specific dose, inhaled, before meals,12 weeks
Intervention Type
Drug
Intervention Name(s)
Injectable Insulin
Intervention Description
Patient specific dose,injected, before meals, 12 weeks
Primary Outcome Measure Information:
Title
Change in HbA1c from baseline
Time Frame
12 and 24 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients who achieve an HbA1c < 7% and <= 6.5%
Time Frame
12 and 24 weeks
Title
Insulin (regular human insulin, insulin lispro, human insulin inhalation powder or insulin glargine)doses
Time Frame
at each visit
Title
8-point self monitoring blood glucose profiles
Time Frame
12 and 24 weeks
Title
Two hour glucose excursions for the morning, midday, and evening meals
Time Frame
12 and 24 weeks
Title
Inhaler reliability
Time Frame
throughout the study
Title
Patient-reported treatment satisfaction and insulin delivery satisfaction
Time Frame
12 and 24 weeks
Title
Preference for the study therapies
Time Frame
week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Kanagawa
ZIP/Postal Code
235-0045
Country
Japan
Facility Name
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.
City
Tokyo
ZIP/Postal Code
160-0023
Country
Japan
Facility Name
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.
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
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.
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
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.
City
Tao-Yuan
ZIP/Postal Code
333
Country
Taiwan

12. IPD Sharing Statement

Citations:
Citation
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.
Results Reference
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A Study for Patients With Type 1 Diabetes Mellitus

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