Six Month Clinical Trial Assessing Efficacy And Safety Of Inhaled Insulin In Type 2 Diabetes

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00424411

Collaborator

(none)

300

Enrollment

Locations

Duration (Months)

6.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To determine, in subjects with Type 2 Diabetes Mellitus:

Whether glycemic control can be achieved at least as effectively with an insulin regimen involving pre-meal EXUBERA™ (inhaled insulin) plus a single bedtime Ultralente injection as with a conventional subcutaneous insulin regimen involving 2 mixed Regular/NPH insulin injections per day.
The toleration and safety of EXUBERA™ (inhaled insulin) therapy and its effects after 6 months, if any, on measures of pulmonary function.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Inhaled human insulin (EXUBERA™)	Phase 3

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Efficacy and Safety of Inhaled Compared With Subcutaneous Human Insulin Therapy in Subjects With Type 2 Diabetes Mellitus: A Six-Month, Outpatient, Parallel Comparative Trial

Study Start Date :

Sep 1, 1999

Study Completion Date :

Dec 1, 2000

Outcome Measures

Primary Outcome Measures

Primary outcome is 24 week change in baseline in HbA1c. []

Secondary Outcome Measures

The secondary endpoints include the following efficacy assessments: []
Incidence of hypoglycemia []
Proportion of subjects with acceptable glycemic control (e.g., HbA1c<8%) []
Change from baseline in fasting lipid profile []
Change from baseline in fasting plasma glucose level []
Change from baseline in meal glucose response (2-hour postprandial increment in plasma glucose) []
Dose of insulin (total dose of injected sustained-duration insulin, and total dose of inhaled or injected Regular insulin during the study). []
Change from baseline in body weight []
Change from baseline in 24-hour home glucose profile (based on the area under the glucose profile curve calculated by the trapezoid rule with special weights assigned to the pre-breakfast and bedtime assessments). []
Patient satisfaction and preference. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Type 2 Diabetes
Stable insulin regimen of at least 2 injections per day

Exclusion Criteria:

Any smoking within the last 6 months. Smoking is not permitted at any time during this study.
Subjects on insulin pump during 2 months prior to screening.
Subjects with poorly-controlled asthma, clinically significant chronic obstructive pulmonary disease, or other significant respiratory disease.

Contacts and Locations

Locations

	Site	City	State	Country
1	Pfizer Investigational Site	Burlingame	California	United States
2	Pfizer Investigational Site	Irvine	California	United States
3	Pfizer Investigational Site	Los Angeles	California	United States
4	Pfizer Investigational Site	Newport Beach	California	United States
5	Pfizer Investigational Site	Orange	California	United States
6	Pfizer Investigational Site	San Diego	California	United States
7	Pfizer Investigational Site	San Francisco	California	United States
8	Pfizer Investigational Site	Tustin	California	United States
9	Pfizer Investigational Site	New Haven	Connecticut	United States
10	Pfizer Investigational Site	Washington	District of Columbia	United States
11	Pfizer Investigational Site	Clearwater	Florida	United States
12	Pfizer Investigational Site	Miami	Florida	United States
13	Pfizer Investigational Site	Tampa	Florida	United States
14	Pfizer Investigational Site	Chicago	Illinois	United States
15	Pfizer Investigational Site	Louisville	Kentucky	United States
16	Pfizer Investigational Site	New Orleans	Louisiana	United States
17	Pfizer Investigational Site	Columbia	Missouri	United States
18	Pfizer Investigational Site	St Louis	Missouri	United States
19	Pfizer Investigational Site	St. Louis	Missouri	United States
20	Pfizer Investigational Site	Omaha	Nebraska	United States
21	Pfizer Investigational Site	New Hyde Park	New York	United States
22	Pfizer Investigational Site	New York	New York	United States
23	Pfizer Investigational Site	Rochester	New York	United States
24	Pfizer Investigational Site	Durham	North Carolina	United States
25	Pfizer Investigational Site	Greenville	North Carolina	United States
26	Pfizer Investigational Site	Winston-salem	North Carolina	United States
27	Pfizer Investigational Site	Cleveland	Ohio	United States
28	Pfizer Investigational Site	Portland	Oregon	United States
29	Pfizer Investigational Site	Austin	Texas	United States
30	Pfizer Investigational Site	Dallas	Texas	United States
31	Pfizer Investigational Site	Irving	Texas	United States
32	Pfizer Investigational Site	San Antonio	Texas	United States
33	Pfizer Investigational Site	Burlington	Vermont	United States
34	Pfizer Investigational Site	Charlottesville	Virginia	United States
35	Pfizer Investigational Site	Renton	Washington	United States
36	Pfizer Investigational Site	Calgary	Alberta	Canada
37	Pfizer Investigational Site	Edmonton	Alberta	Canada
38	Pfizer Investigational Site	Red Deer	Alberta	Canada
39	Pfizer Investigational Site	Winnipeg	Manitoba	Canada
40	Pfizer Investigational Site	St John's	Newfoundland and Labrador	Canada
41	Pfizer Investigational Site	Halifax	Nova Scotia	Canada
42	Pfizer Investigational Site	Mississauga	Ontario	Canada
43	Pfizer Investigational Site	Ottawa	Ontario	Canada
44	Pfizer Investigational Site	Toronto	Ontario	Canada
45	Pfizer Investigational Site	Chomedy	Quebec	Canada
46	Pfizer Investigational Site	Montreal	Quebec	Canada