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

April 13, 2009 updated by: Pfizer

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.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

49

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Pfizer Investigational Site
  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan, 74600
        • Pfizer Investigational Site
  • Philippines
      • 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
        • Pfizer Investigational Site
  • Singapore
      • Singapore, Singapore, 119074
        • Pfizer Investigational Site
      • Singapore, Singapore, 159964
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Severe Asthma, severe COPD
  • Smoking

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Drug: Inhaled Human Insulin (Exubera)
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Drug: Inhaled Human Insulin (Exubera)
Initial dose of 1mg TID of inhaled human insulin
Active Comparator: Control
Drug: Inhaled Human Insulin (Exubera)
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
Drug: Inhaled Human Insulin (Exubera)
Initial dose of 1mg TID of inhaled human insulin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c From Baseline
Time Frame: From baseline to week 16
Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16
From baseline to week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Mean change of fasting plasma glucose, and overall absolute (based on the mean of 7-point home blood glucose monitoring (HGM) values), pre- and post-meal blood glucose (based on the mean of pre- or post-meal HGM values). Change from pre- to post-meal blood glucose based on the mean of difference of pre-meal HGM values from post-meal HGM values.
From baseline to week 16
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia
Time Frame: week 16
Cumulative Number Subjects Who Experienced Hypoglycemia & Nocturnal Hypoglycemia. Hypoglycemia:1)Clinical picture includes prompt resolution with food intake, subcutaneous glucagon, or intravenous glucose, 2)blood glucose check showing glucose <3.27 mmol/L (59 mg/dl), 3)glucose measurement of 2.7 mmol/L (49 mg/dl) or less, with or without symptoms.
week 16
Hypoglycemia Event Rate Per Month
Time Frame: up to week 4 or 16
Monthly event rate was calculated as the daily event rate multiplied by 30, and the daily event rate was calculated as the total number of events divided by the days in study up to the specified timepoint (ie, Week 4 or Week 16).
up to week 4 or 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

February 20, 2007

First Submitted That Met QC Criteria

February 20, 2007

First Posted (Estimate)

February 21, 2007

Study Record Updates

Last Update Posted (Estimate)

May 11, 2009

Last Update Submitted That Met QC Criteria

April 13, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A2171086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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