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NCT00437489 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

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.

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00437489
Other study ID # A2171086
Secondary ID
Status Terminated
Phase Phase 4
First received February 20, 2007
Last updated April 13, 2009
Start date June 2007
Est. completion date December 2007

Study information
Verified date February 2009
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Terminated
Enrollment 49
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diabetes mellitus Type 2

- Currently treated with at least 2 oral anti-diabetic agents

Exclusion Criteria:

- Severe Asthma, severe COPD

- Smoking

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Inhaled Human Insulin (Exubera)
Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID
• Inhaled Human Insulin (Exubera)
Initial dose of 1mg TID of inhaled human insulin

Locations
Country Name City State
Hong Kong Pfizer Investigational Site Hong Kong
Pakistan Pfizer Investigational Site Karachi Sindh
Philippines Pfizer Investigational Site Makati
Philippines Pfizer Investigational Site Marikina City
Philippines Pfizer Investigational Site Pasay City
Philippines Pfizer Investigational Site Pasig City
Philippines Pfizer Investigational Site Quezon City
Singapore Pfizer Investigational Site Singapore
Singapore Pfizer Investigational Site Singapore

Sponsors (1)
Lead Sponsor Collaborator
Pfizer

Countries where clinical trial is conducted

Hong Kong,  Pakistan,  Philippines,  Singapore, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in HbA1c From Baseline From baseline to week 16 No
Secondary 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 No
Secondary Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia week 16 No
Secondary Hypoglycemia Event Rate Per Month up to week 4 or 16 No
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