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

Phase 4

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: Inhaled Human Insulin (Exubera)

• Registration Number: NCT00437489
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-02-20
• Study First Submitted QC: 2007-02-20
• Study First Posted: 2007-02-21
• Study Start: 2007-06
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-12-11
• Status Verified: 2009-02
• Results First Submitted QC: 2009-02-04
• Results First Posted: 2009-03-06
• Last Update Submitted: 2009-04-13
• Last Update Posted: 2009-05-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

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

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Exclusion Criteria

• Severe Asthma, severe COPD
• Smoking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental	Inhaled Human Insulin (Exubera)	-
Control	Inhaled Human Insulin (Exubera)	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline	From baseline to week 16	Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16

Secondary Outcome Measures

Name	Time	Method
Hypoglycemia Event Rate Per Month	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).
Fasting Plasma Glucose, and Overall Absolute, Pre-meal, and Post-meal Blood Glucose Change From Baseline to Week 16 (LOCF)	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.
Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia	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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇸🇬 Singapore, Singapore