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

NCT00437489 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2009-05-11

Study results available
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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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2007-12-31
Completion
2007-12-31

Countries

  • Hong Kong
  • Pakistan
  • Philippines
  • Singapore

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00437489 on ClinicalTrials.gov