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A Clinical Trial Comparing The Efficacy And Safety Of 2 Different Initial Dose Prescriptions For Exubera.

This study has been terminated.
(This protocol was terminated not for safety reasons, but because Pfizer decided to return the worldwide rights for Exubera to Nektar, on 18 October 2007.)
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00437489
First received: February 20, 2007
Last updated: April 13, 2009
Last verified: February 2009
  Purpose

The primary objective of this study is to assess whether a simple initial dose prescription of inhaled insulin (Exubera) achieves glycemic control (HbA1c) after 16 weeks that is non-inferior compared to the standard weight-based formula.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Inhaled Human Insulin (Exubera)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 16 Week Open-Label Outpatient, Randomized, Parallel Study Assessing The Impact Of Two Different Initial Dose Prescriptions For Dry Powder Inhaled Insulin (Exubera®) On Glycemic Control In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Or More Oral Agents.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change in HbA1c From Baseline [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fasting Plasma Glucose, and Overall Absolute, Pre-Meal, and Post-Meal Blood Glucose Change From Baseline to Week 16 (LOCF) [ Time Frame: From baseline to week 16 ] [ Designated as safety issue: No ]
  • Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia [ Time Frame: week 16 ] [ Designated as safety issue: No ]
  • Hypoglycemia Event Rate Per Month [ Time Frame: up to week 4 or 16 ] [ Designated as safety issue: No ]

Enrollment: 49
Study Start Date: June 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control Drug: Inhaled Human Insulin (Exubera)
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Experimental: Experimental Drug: Inhaled Human Insulin (Exubera)
Initial dose of 1mg TID of inhaled human insulin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diabetes mellitus Type 2
  • Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00437489

Locations
Hong Kong
Pfizer Investigational Site
Hong Kong, Hong Kong
Pakistan
Pfizer Investigational Site
Karachi, Sindh, Pakistan, 74600
Philippines
Pfizer Investigational Site
Makati, Philippines, 1218
Pfizer Investigational Site
Marikina City, Philippines, 1810
Pfizer Investigational Site
Pasay City, Philippines, 1300
Pfizer Investigational Site
Pasig City, Philippines, 1605
Pfizer Investigational Site
Quezon City, Philippines, 1102
Singapore
Pfizer Investigational Site
Singapore, Singapore, 119074
Pfizer Investigational Site
Singapore, Singapore, 159964
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00437489     History of Changes
Other Study ID Numbers: A2171086
Study First Received: February 20, 2007
Results First Received: December 11, 2008
Last Updated: April 13, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 24, 2014