A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 1 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere®/Insulin Versus Subcutaneous Basal Insulin and Prandial Insulin Over a 52-Week Treatment Period and a 4-Week Follow-up

Phase 1

• Conditions: Diabetes mellitus type I; MedDRA version: 7.1 Level: PT Classification code 10012601

• Registration Number: EUCTR2006-000306-23-GB
• Lead Sponsor: MannKind Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-05
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 590

Inclusion Criteria

Key inclusion criteria include: non-tobacco smoking (urine cotinine = 100 ng/mL) males or females ages = 18 and = 80 years, with type 1 diabetes currently receiving sc basal/prandial insulin therapy at < 1.4 iu/kg/day, with a body mass index = 35 kg/m2 and a HbA1c of > 7.0% and = 11.0%, Forced Expiratory Volume in 1 Second (FEV1) = 70% predicted (NHANES III), DLco = 80% predicted (Miller) and Total Lung Capacity (TLC) = 80% predicted (ITS). Subjects must have a C-peptide level of = 0.20 pmol/mL.
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: history of active viral and/or cirrhotic hepatic disease and/or abnormal levels of liver enzymes aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) = 3 times the upper limit of normal (ULN), history of chronic obstructive pulmonary disease (COPD), asthma (any history of bronchospasm or asthma after the age of 14), and/or any other clinically important pulmonary disease confirmed by documented history, PFTs or radiologic findings and, evidence of severe complications of diabetes.

Study & Design

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