Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

Sponsor

Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00370565

Collaborator

Sanofi (Industry), Nektar Therapeutics (Industry)

345

Enrollment

Locations

Duration (Months)

6.6

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To assess the impact on glucose control by inhaled insulin alone or added to two oral anti-diabetic agents in patients with type 2 diabetes who are not well controlled on 2 oral anti-diabetic agents.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Inhaled Human Insulin	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 Exubera (Inhaled Insulin) Therapy In Subjects With Type 2 Diabetes Mellitus Not Well Controlled With Combination Oral Agents: A Three-Month, Outpatient, Parallel Comparative Trial.

Study Start Date :

Jun 1, 1999

Study Completion Date :

Sep 1, 2000

Outcome Measures

Primary Outcome Measures

The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization. []
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values. []

Secondary Outcome Measures

Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies) []
Meal glucose response measured at Week -1 and at Week 12; []
These results for efficacy are measured in the lab using plasma samples collected during clinic visits, []
not the subject's home glucose monitoring results. []
Comparison of 24-hour home glucose profiles. []
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight. []
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study. []

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 Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

Exclusion Criteria:

Asthma, COPD
Smoking during the previous 6 months

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Irvine	California	United States	92618
2	Pfizer Investigational Site	Long Beach	California	United States	90806
3	Pfizer Investigational Site	Los Angeles	California	United States	90059
4	Pfizer Investigational Site	Los Angeles	California	United States	90073
5	Pfizer Investigational Site	Newport Beach	California	United States	92663
6	Pfizer Investigational Site	San Diego	California	United States	92108
7	Pfizer Investigational Site	Tustin	California	United States	92780
8	Pfizer Investigational Site	New Britain	Connecticut	United States	06050
9	Pfizer Investigational Site	New Haven	Connecticut	United States	06510
10	Pfizer Investigational Site	New Haven	Connecticut	United States	06519
11	Pfizer Investigational Site	Washington	District of Columbia	United States	20007
12	Pfizer Investigational Site	Clearwater	Florida	United States	33761
13	Pfizer Investigational Site	Hollywood	Florida	United States	33021
14	Pfizer Investigational Site	Miami	Florida	United States	33136
15	Pfizer Investigational Site	Tampa	Florida	United States	33607
16	Pfizer Investigational Site	Louisville	Kentucky	United States	40202
17	Pfizer Investigational Site	New Orleans	Louisiana	United States	70121
18	Pfizer Investigational Site	Minneapolis	Minnesota	United States	55416
19	Pfizer Investigational Site	Columbia	Missouri	United States	65212
20	Pfizer Investigational Site	St. Louis	Missouri	United States	63141
21	Pfizer Investigational Site	Omaha	Nebraska	United States	68131
22	Pfizer Investigational Site	New York	New York	United States	10016
23	Pfizer Investigational Site	New York	New York	United States	10025
24	Pfizer Investigational Site	Rochester	New York	United States	14642
25	Pfizer Investigational Site	Greenville	North Carolina	United States	27858
26	Pfizer Investigational Site	Winston-salem	North Carolina	United States	27157
27	Pfizer Investigational Site	Cleveland	Ohio	United States	44195
28	Pfizer Investigational Site	Portland	Oregon	United States	97201-3098
29	Pfizer Investigational Site	Philadelphia	Pennsylvania	United States	19104
30	Pfizer Investigational Site	Austin	Texas	United States	78758
31	Pfizer Investigational Site	Dallas	Texas	United States	75230
32	Pfizer Investigational Site	Dallas	Texas	United States	75235-8858
33	Pfizer Investigational Site	Dallas	Texas	United States	75246
34	Pfizer Investigational Site	Irving	Texas	United States	75061
35	Pfizer Investigational Site	San Antonio	Texas	United States	78229
36	Pfizer Investigational Site	Burlington	Vermont	United States	05401
37	Pfizer Investigational Site	Renton	Washington	United States	98055
38	Pfizer Investigational Site	Calgary	Alberta	Canada	T3B 0M3
39	Pfizer Investigational Site	Edmonton	Alberta	Canada	T5H 3V9
40	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 2C8
41	Pfizer Investigational Site	Edmonton	Alberta	Canada	T6G 2S2
42	Pfizer Investigational Site	Red Deer	Alberta	Canada	T4N 6V7
43	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3A 1R9
44	Pfizer Investigational Site	Winnipeg	Manitoba	Canada	R3E 3P4
45	Pfizer Investigational Site	St John's	Newfoundland and Labrador	Canada	A1B 3V6
46	Pfizer Investigational Site	Halifax	Nova Scotia	Canada	B3H 2Y9
47	Pfizer Investigational Site	Ottawa	Ontario	Canada	K1Y 4E9
48	Pfizer Investigational Site	Toronto	Ontario	Canada	M5B 1WB
49	Pfizer Investigational Site	Toronto	Ontario	Canada	M5C 2T2
50	Pfizer Investigational Site	Toronto	Ontario	Canada	M5G 1X5
51	Pfizer Investigational Site	Toronto	Ontario	Canada	M5G 2C4
52	Pfizer Investigational Site	Laval	Quebec	Canada	H7T 2P5