search
Back to results

A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Insulin Glargine (Lantus®)
Inhaled Human Insulin (Exubera®)
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring type 2 diabetes, insulin, glycemic control

Eligibility Criteria

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

Inclusion Criteria:

  • Diabetes Mellitus, Type 2 on oral agents
  • Age > 30 years

Exclusion Criteria:

  • Severe Asthma, severe Chronic Obstructive Pulmonary Disease
  • Smoking

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Insulin Glargine (Lantus®)

Inhaled Human Insulin (Exubera®)

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.

Secondary Outcome Measures

Change From Baseline in HbA1c Prior to Week 26
Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.
Number of Subjects With HbA1c < 6.5 %
Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.
Number of Subjects With HbA1c < 7.0 %
Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.
Number of Subjects With HbA1c < 8.0 %
Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.
Change From Baseline in Fasting Plasma Glucose (FPG) Level
FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.
Number of Subjects With Hypoglycemic Events by Severity
Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.
Number of Events of Nocturnal Hypoglycemia
Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.
Change From Baseline in Body Weight
Change from baseline calculated as body weight at observation minus body weight at baseline.
Change From Baseline in Body Mass Index (BMI)
BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
Number of Subjects Discontinued Due to Insufficient Clinical Response
Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.
Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health
Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.
Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.
Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.
Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.
Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.
Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.
Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects
Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.

Full Information

First Posted
October 19, 2006
Last Updated
June 30, 2015
Sponsor
Pfizer
search

1. Study Identification

Unique Protocol Identification Number
NCT00391027
Brief Title
A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®
Official Title
A Six Month, Open-Label Outpatient, Randomized Parallel Group Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control Compared To Insulin Glargine (Lantus®) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To compare efficacy and safety of Exubera® vs Lantus® in patients with type 2 diabetes mellitus.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
type 2 diabetes, insulin, glycemic control

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
261 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Insulin Glargine (Lantus®)
Arm Type
Active Comparator
Arm Title
Inhaled Human Insulin (Exubera®)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Insulin Glargine (Lantus®)
Intervention Description
Patient will be randomized to Lantus® while remaining on pre-study oral hypoglycemic agents.
Intervention Type
Drug
Intervention Name(s)
Inhaled Human Insulin (Exubera®)
Intervention Description
Patient will be randomized inhaled insulin while remaining on pre-study oral hypoglycemic agents.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26
Description
Change (measured as percent): HbA1c at observation minus HbA1c at baseline. Primary objective to demonstrate non-inferiority of inhaled insulin compared to insulin glargine for glycemic control after 26 weeks of treatment not attainable due to early termination of study; analyses were descriptive and graphical.
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in HbA1c Prior to Week 26
Description
Change (measured as percent) from baseline calculated as HbA1c at observation minus HbA1c at baseline.
Time Frame
Baseline, Week 2, Week 4, Week 8, Week 12, and Week 18
Title
Number of Subjects With HbA1c < 6.5 %
Description
Number of subjects with glycemic control HbA1c measurement of < 6.5 % at observation.
Time Frame
Week 26
Title
Number of Subjects With HbA1c < 7.0 %
Description
Number of subjects with glycemic control HbA1c measurement of < 7.0 % at observation.
Time Frame
Week 26
Title
Number of Subjects With HbA1c < 8.0 %
Description
Number of subjects with glycemic control HbA1c measurement of < 8.0 % at observation.
Time Frame
Week 26
Title
Change From Baseline in Fasting Plasma Glucose (FPG) Level
Description
FPG measured as milligrams/deciliter (mg/dl). Change from baseline calculated as FPG at observation minus FPG at baseline.
Time Frame
Baseline, Week 26
Title
Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)
Description
Blood glucose (BG) self-monitored by subject at home; measured at least once between Visits 2, 3 and between Visits 8, 9 (8-point: fasting, pre-meal, post-meal, bedtime, 2:00 am); between each visit: Visit 3 to 8 (7-point: fasting, post-meal, pre-lunch, pre-dinner, bedtime). Post-meal: 2-hour period after breakfast, lunch, dinner. Change: average overall absolute, pre-meal, and post-meal blood glucose = HBGM at observation minus HBGM at baseline; pre-meal to post-meal blood glucose = HBGM at post-meal minus HBGM at pre-meal.
Time Frame
Baseline, Week 26
Title
Number of Subjects With Hypoglycemic Events by Severity
Description
Number of subjects with hypoglycemic events by severity. Severe hypoglycemia: subject unable to treat self; exhibits a neurological symptom; and blood glucose <=2.72 mmol/L or blood glucose not measured but symptoms reversed with food intake, SC glucagon, or intravenous glucose. If all 3 criteria not met, hypoglycemia defined as mild or moderate.
Time Frame
Week 26
Title
Number of Events of Nocturnal Hypoglycemia
Description
Number of events of nocturnal hypoglycemia, incidence: midnight to 6:00 am. Hypoglycemia: characteristic symptoms of hypoglycemia with no blood glucose check; resolved with food intake, SC glucagon, or intravenous (IV) glucose; or symptoms with glucose <3.27 mmol/L (59 mg/dL); or any glucose measurement <=2.72 mmol/L (49 mg/dl). Severity of nocturnal glycemia not summarized.
Time Frame
Week 26
Title
Change From Baseline in Body Weight
Description
Change from baseline calculated as body weight at observation minus body weight at baseline.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Body Mass Index (BMI)
Description
BMI measured as kilograms per meter squared (kg/m2). Change calculated as BMI at observation minus BMI at baseline.
Time Frame
Baseline, Week 26
Title
Number of Subjects Discontinued Due to Insufficient Clinical Response
Description
Number of subjects discontinued due to signs and symptoms of persistent hyperglycemia or HbA1c > 12.0 % or frequent and unexplained severe hypoglycemic events (> 3 events per month for 2 or more months); subject's HbA1c not < = 7 % at Week 12.
Time Frame
Week 26
Title
Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health
Description
Subject reported outcomes for Diabetes Treatment Satisfaction Questionnaire-Status (DTSQs), DTSQ-change, Patient Satisfaction with Insulin Therapy-16 item, Mental Health Inventory-17 item, and Euro Quality of life 5-Dimensions (EuroQol 5-D) Questionnaire not summarized due to cancellation of Exubera® program.
Time Frame
Week 26
Title
Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients
Description
The mean of the 24-hour mean and the mean of the 24-hour standard deviation (SD) (variability around the average glucose concentration) calculated on glucose values (mg/dl) collected during inpatient evaluation of glycemic stability. Interstitial glucose assessed at 5 minute intervals starting pre-supper on Day 1 of evaluation; ending on Day 3 pre-breakfast. Analysis is on data generated between 6:00 am on Day 2 and 6:00 am on Day 3.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)
Description
Change from baseline in CV biomarker hs-CRP (milligrams per deciliter [mg/dl]) calculated as hs-CRP at observation minus hs-CRP at baseline.
Time Frame
Baseline, Week 26
Title
Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)
Description
Change from baseline in IL-6 (picograms per milliliter [pg/ml]) calculated as IL-6 at observation minus IL-6 at baseline.
Time Frame
Baseline, Week 26
Title
Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)
Description
Change from baseline in tat-complexes (nanograms per milliliter [ng/ml]) calculated as tat-complexes at observation minus tat-complexes at baseline.
Time Frame
Baseline, Week 26
Title
Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)
Description
Change from baseline in soluble tissue factor (pg/ml) calculated as STF at observation minus STF at baseline.
Time Frame
Baseline, Week 26
Title
Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects
Description
Urinary free 8-iso prostaglandin F2-alpha (α): compare glucose fluctuations and activation of oxidative stress as assessed by urinary isoprostanes in a subset of subjects randomized to either Exubera® or subcutaneous insulin glargine. The substudy was offered to all subjects. Data not summarized due to cancellation of Exubera® program.
Time Frame
Baseline, Week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diabetes Mellitus, Type 2 on oral agents Age > 30 years Exclusion Criteria: Severe Asthma, severe Chronic Obstructive Pulmonary Disease Smoking
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Bornem
ZIP/Postal Code
2800
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Genk
ZIP/Postal Code
3600
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Liège 1
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Facility Name
Pfizer Investigational Site
City
Lahti
ZIP/Postal Code
15110
Country
Finland
Facility Name
Pfizer Investigational Site
City
Oulu
ZIP/Postal Code
90100
Country
Finland
Facility Name
Pfizer Investigational Site
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Pfizer Investigational Site
City
Corbeil Essonnes Cedex
ZIP/Postal Code
91106
Country
France
Facility Name
Pfizer Investigational Site
City
LA Rochelle CEDEX
ZIP/Postal Code
17019
Country
France
Facility Name
Pfizer Investigational Site
City
Marseille Cedex 5
ZIP/Postal Code
13385
Country
France
Facility Name
Pfizer Investigational Site
City
Paris Cedex 10
ZIP/Postal Code
75475
Country
France
Facility Name
Pfizer Investigational Site
City
Valenciennes Cedex 1
ZIP/Postal Code
59300
Country
France
Facility Name
Pfizer Investigational Site
City
Altenburg
ZIP/Postal Code
04600
Country
Germany
Facility Name
Pfizer Investigational Site
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hamburg
ZIP/Postal Code
20253
Country
Germany
Facility Name
Pfizer Investigational Site
City
Hohenmoelsen
ZIP/Postal Code
06679
Country
Germany
Facility Name
Pfizer Investigational Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Pfizer Investigational Site
City
Neuss
ZIP/Postal Code
41460
Country
Germany
Facility Name
Pfizer Investigational Site
City
Riesa
ZIP/Postal Code
01587
Country
Germany
Facility Name
Pfizer Investigational Site
City
Wangen / Allgaeu
ZIP/Postal Code
88239
Country
Germany
Facility Name
Pfizer Investigational Site
City
Den Bosch
ZIP/Postal Code
5233 VG
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Den Haag
ZIP/Postal Code
2512 VA
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Eindhoven
ZIP/Postal Code
5631 BM
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Nijmegen
ZIP/Postal Code
6525 EC
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Venlo
ZIP/Postal Code
5912 BL
Country
Netherlands
Facility Name
Pfizer Investigational Site
City
Honefoss
State/Province
Buskerud
ZIP/Postal Code
3505
Country
Norway
Facility Name
Pfizer Investigational Site
City
Bergen
ZIP/Postal Code
5012
Country
Norway
Facility Name
Pfizer Investigational Site
City
Jessheim
ZIP/Postal Code
2050
Country
Norway
Facility Name
Pfizer Investigational Site
City
Lysaker
Country
Norway
Facility Name
Pfizer Investigational Site
City
Skedsmokorset
ZIP/Postal Code
N-2020
Country
Norway
Facility Name
Pfizer Investigational Site
City
Lask
ZIP/Postal Code
98-100
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
90-030
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-338
Country
Poland
Facility Name
Pfizer Investigational Site
City
Lublin
ZIP/Postal Code
20-536
Country
Poland
Facility Name
Pfizer Investigational Site
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Pfizer Investigational Site
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07014
Country
Spain
Facility Name
Pfizer Investigational Site
City
Inca
State/Province
Mallorca
ZIP/Postal Code
07300
Country
Spain
Facility Name
Pfizer Investigational Site
City
La Laguna
State/Province
Santa Cruz de Tenerife
ZIP/Postal Code
38320
Country
Spain
Facility Name
Pfizer Investigational Site
City
Alzira
State/Province
Valencia
ZIP/Postal Code
46600
Country
Spain
Facility Name
Pfizer Investigational Site
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Huelva
ZIP/Postal Code
21080
Country
Spain
Facility Name
Pfizer Investigational Site
City
Malaga
ZIP/Postal Code
29006
Country
Spain
Facility Name
Pfizer Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
Pfizer Investigational Site
City
Boras
ZIP/Postal Code
501 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Eksjo
ZIP/Postal Code
575 36
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
412 55
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Goteborg
ZIP/Postal Code
41665
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Harnosand
ZIP/Postal Code
871 82
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Helsingborg
ZIP/Postal Code
25220
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Järfälla
ZIP/Postal Code
177 31
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Kristianstad
ZIP/Postal Code
291 54
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Linkoping
ZIP/Postal Code
581 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Lulea
ZIP/Postal Code
972 33
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Malmo
ZIP/Postal Code
211 52
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Motala
ZIP/Postal Code
591 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Stockholm
ZIP/Postal Code
118 83
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Uddevalla
ZIP/Postal Code
451 50
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Umea
ZIP/Postal Code
901 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Vaxjo
ZIP/Postal Code
351 85
Country
Sweden
Facility Name
Pfizer Investigational Site
City
Bruderholz
ZIP/Postal Code
4101
Country
Switzerland
Facility Name
Pfizer Investigational Site
City
St. Gallen
ZIP/Postal Code
CH-9007
Country
Switzerland

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2171084&StudyName=A%20Clinical%20Trial%20Comparing%20the%20Efficacy%20and%20Safety%20of%20Exubera%AE%20and%20Lantus%AE
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

A Clinical Trial Comparing the Efficacy and Safety of Exubera® and Lantus®

We'll reach out to this number within 24 hrs