Effect on Glycemic Control of Inhaled Insulin Alone or Added to Dual Oral Therapy After Failure of Dual Oral Therapy.

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2

• Registration Number: NCT00370565
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1999-06
• Study Completion: 2000-09
• Study First Submitted: 2006-08-29
• Study First Submitted QC: 2006-08-29
• Study First Posted: 2006-08-31
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-09
• Last Update Posted: 2007-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 345

Inclusion Criteria

• Type 2 Diabetes Mellitus as defined by American Diabetes Association (ADA) at least 1 year earlier.
• Patients were required to have been treated with a stable oral agent regimen involving 2 antidiabetc medications: 1 insulin secretagogue (a sulfonylurea or replabinide) and 1 insulin sensitizer (a thiazolidinedione or metformin).

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Exclusion Criteria

• Asthma, COPD
• Smoking during the previous 6 months

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary efficacy endpoint is the change from baseline HbA1c measured at 12 weeks after randomization.
HbA1c is measured at Weeks -4, -1, 0, 6, and 12 of comparative treatment. The baseline value is the mean of the Week -1 and Week 0 values.

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with acceptable or good glycemic control (e.g., HbA1c < 8.0% or <7.0%) at the end of treatment, incidence and severity of hypoglycemic episodes, discontinuation rate, change in fasting lipid profile, and change in body weight.
Secondary: Efficacy: change in fasting plasma glucose and meal glucose response (2-h postprandial increment in plasma glucose)Fasting plasma glucose measured at Weeks -4, -1, 0, and 12 (the Weeks -1 and 12 measurements will be part of the meal studies)
Meal glucose response measured at Week -1 and at Week 12;
These results for efficacy are measured in the lab using plasma samples collected during clinic visits,
not the subject's home glucose monitoring results.
Comparison of 24-hour home glucose profiles.
A patient satisfaction and preference questionnaire will be administered at screening, at baseline, during active therapy, and at the end of the study.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇨🇦 Laval, Quebec, Canada