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

NCT00437489 | Terminated Phase 4 Results

• 1 other identifier: A2171086
• Study Type: interventional
• Target: 49
• Locations: 4 countries
• Sites: 9

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline

  Mean change of hemoglobin A1c (HbA1c %) from baseline to week 16

  From baseline to week 16

Secondary Outcomes (3)

• 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

• Number of Subjects Who Experienced Hypoglycemia and Nocturnal Hypoglycemia

  week 16

• Hypoglycemia Event Rate Per Month

  up to week 4 or 16

Study Arms (2)

Control

ACTIVE COMPARATOR

Drug: Inhaled Human Insulin (Exubera)

Experimental

EXPERIMENTAL

Drug: Inhaled Human Insulin (Exubera)

Interventions

Inhaled Human Insulin (Exubera) DRUG

Initial dose (mg) as per weight based formula = 0.05 x body weight (kg) TID

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Severe Asthma, severe COPD
• Smoking

Sponsors & Collaborators

• Pfizer: lead

Study Sites (9)

Pfizer Investigational Site

Hong Kong, Hong Kong

Location

Pfizer Investigational Site

Karachi, Sindh, 74600, Pakistan

Location

Pfizer Investigational Site

Makati, 1218, Philippines

Location

Pfizer Investigational Site

Marikina City, 1810, Philippines

Location

Pfizer Investigational Site

Pasay, 1300, Philippines

Location

Pfizer Investigational Site

Pasig, 1605, Philippines

Location

Pfizer Investigational Site

Quezon City, 1102, Philippines

Location

Pfizer Investigational Site

Singapore, 119074, Singapore

Location

Pfizer Investigational Site

Singapore, 159964, Singapore

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Exubera

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

As a result of Pfizer's decision (18Oct2007) to return the worldwide rights for Exubera (insulin human \[rDNA origin\]) Inhalation Powder) to Nektar, from which Pfizer licensed inhaled insulin technology, it was decided to terminate this study.

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 20, 2007
• First Posted: February 21, 2007
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: May 11, 2009
• Results First Posted: March 6, 2009

Record last verified: 2009-02

Locations

PA (1); PH (5); SG (2); HK (1)