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

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ClinicalTrials.gov Identifier: NCT00437489
Recruitment Status : 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.)
First Posted : February 21, 2007
Results First Posted : March 6, 2009
Last Update Posted : May 11, 2009
Sponsor:
Information provided by:
Pfizer

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Inhaled Human Insulin (Exubera) Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Change in HbA1c From Baseline [ Time Frame: From baseline to week 16 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia [ Time Frame: week 16 ]
  3. Hypoglycemia Event Rate Per Month [ Time Frame: up to week 4 or 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00437489     History of Changes
Other Study ID Numbers: A2171086
First Posted: February 21, 2007    Key Record Dates
Results First Posted: March 6, 2009
Last Update Posted: May 11, 2009
Last Verified: February 2009

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