A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

Phase 3

Terminated

• Conditions: Diabetes Mellitus Type 2
• Interventions: Drug: Inhaled Insulin (Exubera); Other: Standard of Care

• Registration Number: NCT00282971
• Lead Sponsor: Pfizer

Brief Summary

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-01-26
• Study First Submitted QC: 2006-01-26
• Study First Posted: 2006-01-27
• Study Start: 2006-03-06
• Primary Completion: 2008-02-19
• Study Completion: 2008-02-19
• Results First Submitted: 2009-02-11
• Results First Submitted QC: 2009-07-17
• Results First Posted: 2009-08-26
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-01
• Last Update Posted: 2019-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 354

Inclusion Criteria

• Diabetes mellitus type 2
• Failing two or more oral anti-diabetic agents

Exclusion Criteria

• Asthma, COPD
• Smoking

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inhaled Insulin	Inhaled Insulin (Exubera)	Inhaled insulin plus oral therapy
Standard of Care	Standard of Care	Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators

Primary Outcome Measures

Name	Time	Method
Percentage Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	4, 12 and 24 weeks	\[(week 24 value - baseline value)/baseline value\]\*100%

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Glycemic Control by Visit	4, 12 and 24 weeks	2 definitions of good glycemic control were used: an HbA1c result of ≤6.5% or ≤7.0%
Change From Baseline in FEV1 at Week 24 LOCF	24 weeks

Trial Locations

Locations (63)

Gain Medical Center; 🇨🇦 Coquitlam, British Columbia, Canada

Misericordia Health Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Maritime Research Center; 🇨🇦 Bathurst, New Brunswick, Canada

Office of Dr. Salim Sunderji; 🇨🇦 London, Ontario, Canada

Orillia Soldier's Memorial Hospital; 🇨🇦 Orillia, Ontario, Canada

Douglas Tweel M.D. Professional Corporation; 🇨🇦 Charlottetown, Prince Edward Island, Canada

Laboratoire Sante Le Gaspesien Inc.; 🇨🇦 Bonaventure, Quebec, Canada

Centre de santé et de services sociaux de Chicoutimi, Centre de médecine genique communataire; 🇨🇦 Chicoutimi, Quebec, Canada

Rhodin Recherche Clinique; 🇨🇦 Drummondville, Quebec, Canada

Q & T Research Outaouais Inc.; 🇨🇦 Gatineau, Quebec, Canada

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