A Clinical Trial Comparing Efficacy and Safety of Exubera® and Humalog®

NCT00356421 | Terminated Phase 4 Results

• 1 other identifier: A2171035
• Study Type: interventional
• Target: 58
• Locations: 13 countries
• Sites: 23

Brief Summary

To compare efficacy and safety of Exubera® vs Humalog in patients with type 1 diabetes mellitus

Conditions

Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Glycosylated Hemoglobin (HbA1c) Percent (%)

  As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera ® (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study. No efficacy data were summarized due to limited enrollment/early termination.

  At 52 weeks

Secondary Outcomes (13)

• Percentage of Subjects Who Attained HbA1c Levels of <8%, <7%, <6.5%, and >=8%

  At 52 weeks

• Percentage of Subjects With Absolute Reduction in HbA1c Levels From Baseline of >0.5%, >0.7% and >1.0%

  At 52 weeks

• Percentage of Subjects Who Attained Target Fasting Plasma Glucose (FPG) Values (4.0 to 6.5 mmol/l; 72 to 117 mg/dl) From Baseline

  At weeks 2, 4, 6, 12, 24, 36, and 52 or last observation.

• Change From Baseline in FPG

  At 52 weeks or last observation

• Change From Baseline in Fasting Blood Glucose Based on Glucometer Data and In-hospital Assessments

  To 52 weeks

Other Outcomes (2)

• Subject Reported Health State From Baseline as Measured in the EuroQol-5 Dimensions (EQ-5D) Questionnaire

  At weeks 6, 24, and 52 or last observation

• Subject Reported Quality of Life From Baseline as Determined From Phase V System Measurement

  At weeks 6, 24, and 52 or last observation

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: Insulin lispro (Humalog)

Experimental

EXPERIMENTAL

Drug: Inhaled Human Insulin (Exubera®)

Interventions

Inhaled Human Insulin (Exubera®) DRUG

Preprandial inhaled insulin regimen and administration of insulin glargine QD

Experimental

Insulin lispro (Humalog) DRUG

Subcutaneous insulin regimen of pre-prandial insulin lispro and administration of insulin glargine QD.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diabetes mellitus Type 1

You may not qualify if:

• Severe Asthma, severe Chronic Obstructive Pulmonary Disease (COPD)
• Smoking

Sponsors & Collaborators

• Pfizer: lead

Study Sites (23)

Pfizer Investigational Site

Hamilton, New Jersey, 08610, United States

Location

Pfizer Investigational Site

New Brunswick, New Jersey, 08903, United States

Location

Pfizer Investigational Site

Vienna, A-1030, Austria

Location

Pfizer Investigational Site

Vienna, A-1130, Austria

Location

Pfizer Investigational Site

Edegem, 2650, Belgium

Location

Pfizer Investigational Site

Genk, 3600, Belgium

Location

Pfizer Investigational Site

Leuven, 3000, Belgium

Location

Pfizer Investigational Site

Aarhus, 8000, Denmark

Location

Pfizer Investigational Site

Kuopio, 70211, Finland

Location

Pfizer Investigational Site

Brest, 29609, France

Location

Pfizer Investigational Site

Corbeil-Essonnes, 91106, France

Location

Pfizer Investigational Site

Strasbourg, 67091, France

Location

Pfizer Investigational Site

Waterford, Ireland

Location

Pfizer Investigational Site

Amsterdam, NL-1105 AZ, Netherlands

Location

Pfizer Investigational Site

Stavanger, 4095, Norway

Location

Pfizer Investigational Site

Lisbon, 1349-019, Portugal

Location

Pfizer Investigational Site

Las Palmas, LAS Palmas de GRAN Canaria, 35016, Spain

Location

Pfizer Investigational Site

Valencia, Valencia, 46010, Spain

Location

Pfizer Investigational Site

Stockholm, 171 76, Sweden

Location

Pfizer Investigational Site

Stockholm, 182 88, Sweden

Location

Pfizer Investigational Site

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Pfizer Investigational Site

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Pfizer Investigational Site

Birmingham, West Midlands, B9 5SS, United Kingdom

Location

Related Links

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

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Exubera; Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

As a result of Pfizer's decision to stop marketing Exubera ®, this study was terminated. Due to the early termination of the study and the low number of subjects who completed, no descriptive statistics for efficacy endpoints are provided.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 24, 2006
• First Posted: July 26, 2006
• Study Start: November 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: September 2, 2009
• Results First Posted: August 11, 2009

Record last verified: 2009-01

Locations

SE (2); FI (1); FR (3); AU (2); NL (1); GB (3); PT (1); BE (3); IE (1); US (2); NO (1); DK (1); ES (2)