A Phase 3, 24-Week, Multi-Center, Open-Label, Randomized, Controlled Trial Comparing the Efficacy and Safety of Prandial Inhalation of Technosphere®/Insulin in Combination with Metformin or Technosphere®/Insulin Alone Versus 2 Oral Anti-Diabetic Agents (Metformin and a Secretagogue) in Subjects With Type 2 Diabetes Mellitus Sub-Optimally Controlled on Combination Metformin and a Secretagogue

• Conditions: Diabetes mellitus type II; MedDRA version: 8.1Level: LLTClassification code 10012601Term: Diabetes mellitus

• Registration Number: EUCTR2006-002245-36-CZ
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-10-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 525

Inclusion Criteria

Key inclusion criteria include: Non-smoking male and female subjects = 18 and = 80 years of age with clinical diagnosis of type 2 diabetes mellitus for = 6 months. Stable regimen of metformin = 1000 mg/day (or maximum tolerated dose) and a secretagogue (sulfonylurea or meglitinide) = ½ the maximum manufacturer-recommended daily dose (or maximum tolerated dose) without any dose adjustments within the preceding 6 weeks. Fixed dose combination products of metformin and sulfonylurea are acceptable as long as each individual dose meets inclusion criteria. HbA1c = 7.5% and = 11.0%. Body Mass Index (BMI) = 40 kg/m2. The following PFTs: FEV1 = 70 % National Health and Nutrition Examination Survey (NHANES) III Predicted, Total Lung Capacity (TLC) = 80% of Predicted (ITS) and single breath carbon monoxide diffusing capacity (DLco (unc)) = 80% of Predicted (Miller).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Key exclusion criteria include: Treatment with any type of anti-diabetic therapy, other than metformin and secretagogues (sulfonylureas or meglitinides), within the preceding 12 weeks. Serum creatinine > 1.4 mg/dL in female subjects and > 1.5 mg/dL in male subjects. History of chronic obstructive pulmonary disease (COPD), clinically proven asthma and/or any other clinically important pulmonary disease confirmed by pulmonary function testing and/or radiologic findings. Evidence of serious complications of diabetes (eg, autonomic neuropathy).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified