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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Insulin Glargine (Lantus®) (Drug); Inhaled Human Insulin (Exubera®) (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

Summary

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 26

Secondary outcome:

Change From Baseline in HbA1c Prior to Week 26

Number of Subjects With HbA1c < 6.5 %

Number of Subjects With HbA1c < 7.0 %

Number of Subjects With HbA1c < 8.0 %

Change From Baseline in Fasting Plasma Glucose (FPG) Level

Analysis of Home Blood Glucose Monitoring (HBGM) (7 & 8 Point)

Number of Subjects With Hypoglycemic Events by Severity

Number of Events of Nocturnal Hypoglycemia

Change From Baseline in Body Weight

Change From Baseline in Body Mass Index (BMI)

Number of Subjects Discontinued Due to Insufficient Clinical Response

Change From Baseline in Treatment Satisfaction, Quality of Life, and Mental Health

Continuous Glucose Monitoring System (CGMS) 24-hour Glucose Profile in a Subset of Patients

Change From Baseline in Cardiovascular (CV) Biomarkers - High Sensitive C-reactive Protein (Hs-CRP)

Change From Baseline in CV Biomarkers - Interleukin 6 (IL-6)

Change From Baseline in CV Biomarkers - Thrombin-antithrombin Complexes (Tat-complexes)

Change From Baseline in CV Biomarkers - Soluble Tissue Factor (STF)

Change From Baseline in Urinary Free 8-iso Prostaglandin F2-alpha (α) in a Subset of Subjects

Eligibility

Minimum age: 30 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Diabetes Mellitus, Type 2 on oral agents

- Age > 30 years

Exclusion Criteria:

- Severe Asthma, severe Chronic Obstructive Pulmonary Disease

- Smoking

Locations and Contacts

Pfizer Investigational Site, Bornem 2800, Belgium

Pfizer Investigational Site, Brussels 1070, Belgium

Pfizer Investigational Site, Genk 3600, Belgium

Pfizer Investigational Site, Liège 1 4000, Belgium

Pfizer Investigational Site, Kuopio 70210, Finland

Pfizer Investigational Site, Lahti 15110, Finland

Pfizer Investigational Site, Oulu 90100, Finland

Pfizer Investigational Site, Besancon 25030, France

Pfizer Investigational Site, Corbeil Essonnes Cedex 91106, France

Pfizer Investigational Site, LA Rochelle CEDEX 17019, France

Pfizer Investigational Site, Marseille Cedex 5 13385, France

Pfizer Investigational Site, Paris Cedex 10 75475, France

Pfizer Investigational Site, Valenciennes Cedex 1 59300, France

Pfizer Investigational Site, Altenburg 04600, Germany

Pfizer Investigational Site, Eisenach 99817, Germany

Pfizer Investigational Site, Hamburg 20253, Germany

Pfizer Investigational Site, Hohenmoelsen 06679, Germany

Pfizer Investigational Site, Leipzig 04103, Germany

Pfizer Investigational Site, Neuss 41460, Germany

Pfizer Investigational Site, Riesa 01587, Germany

Pfizer Investigational Site, Wangen / Allgaeu 88239, Germany

Pfizer Investigational Site, Den Bosch 5233 VG, Netherlands

Pfizer Investigational Site, Den Haag 2512 VA, Netherlands

Pfizer Investigational Site, Eindhoven 5631 BM, Netherlands

Pfizer Investigational Site, Nijmegen 6525 EC, Netherlands

Pfizer Investigational Site, Venlo 5912 BL, Netherlands

Pfizer Investigational Site, Bergen 5012, Norway

Pfizer Investigational Site, Jessheim 2050, Norway

Pfizer Investigational Site, Lysaker, Norway

Pfizer Investigational Site, Skedsmokorset N-2020, Norway

Pfizer Investigational Site, Lask 98-100, Poland

Pfizer Investigational Site, Lodz 90-030, Poland

Pfizer Investigational Site, Lodz 93-338, Poland

Pfizer Investigational Site, Lublin 20-536, Poland

Pfizer Investigational Site, Warszawa 02-097, Poland

Pfizer Investigational Site, A Coruña 15006, Spain

Pfizer Investigational Site, Huelva 21080, Spain

Pfizer Investigational Site, Malaga 29006, Spain

Pfizer Investigational Site, Valencia 46015, Spain

Pfizer Investigational Site, Boras 501 82, Sweden

Pfizer Investigational Site, Eksjo 575 36, Sweden

Pfizer Investigational Site, Goteborg 412 55, Sweden

Pfizer Investigational Site, Goteborg 41665, Sweden

Pfizer Investigational Site, Harnosand 871 82, Sweden

Pfizer Investigational Site, Helsingborg 25220, Sweden

Pfizer Investigational Site, Järfälla 177 31, Sweden

Pfizer Investigational Site, Kristianstad 291 54, Sweden

Pfizer Investigational Site, Linkoping 581 85, Sweden

Pfizer Investigational Site, Lulea 972 33, Sweden

Pfizer Investigational Site, Malmo 211 52, Sweden

Pfizer Investigational Site, Motala 591 85, Sweden

Pfizer Investigational Site, Stockholm 118 83, Sweden

Pfizer Investigational Site, Uddevalla 451 50, Sweden

Pfizer Investigational Site, Umea 901 85, Sweden

Pfizer Investigational Site, Vaxjo 351 85, Sweden

Pfizer Investigational Site, Bruderholz 4101, Switzerland

Pfizer Investigational Site, St. Gallen CH-9007, Switzerland

Pfizer Investigational Site, Honefoss, Buskerud 3505, Norway

Pfizer Investigational Site, Palma de Mallorca, Islas Baleares 07014, Spain

Pfizer Investigational Site, Inca, Mallorca 07300, Spain

Pfizer Investigational Site, La Laguna, Santa Cruz de Tenerife 38320, Spain

Pfizer Investigational Site, Alzira, Valencia 46600, Spain

Additional Information

To obtain contact information for a study center near you, click here.

Starting date: December 2006
Last updated: June 30, 2015

Page last updated: August 23, 2015

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