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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-000306-23-GB

Enrollment

590

Registered

2006-05-05

Start date

2006-07-14

Completion date

Unknown

Last updated

2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Product Name: Technosphere®/Insulin Pharmaceutical Form: Inhalation powder, pre-dispensed INN or Proposed INN: Insulin Human rDNA CAS Number: 11061-68-0

Eligibility

Sex/Gender

All

Inclusion criteria

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 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this clinical trial is to compare the efficacy (as expressed by the change of HbA1c) over a 52-week period of prandial administration of Technosphere®/Insulin (T/I) + basal insulin therapy (T/I group) versus prandial subcutaneous (sc) insulin treatment + basal insulin treatment (comparator group) in subjects with type 1 diabetes previously treated with a basal/prandial regimen.; Secondary Objective: The secondary objectives of this clinical trial are to: 1. Evaluate the safety of T/I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events (AEs) and pulmonary function tests (PFTs); 2. Compare the area under the curve (AUC) postprandial venous plasma glucose values following a standardized liquid meal from 0-360 minutes; 3. Evaluate the proportion of subjects with HbA1c = 6.5%, = 7.0%, and = 8.0%; 4. Evaluate changes in the SF-36 Quality of Life (QoL) instrument between treatment groups; and, 5. Evaluate changes from the Insulin Treatment Questionnaire (ITQ) between treatment groups. ;Primary end point(s): The primary endpoint is to compare the mean change from baseline to Week 52 in HbA1c values between treatment groups.	—

Measure

Time frame

Main Objective: The primary objective of this clinical trial is to compare the efficacy (as expressed by the change of HbA1c) over a 52-week period of prandial administration of Technosphere®/Insulin (T/I) + basal insulin therapy (T/I group) versus prandial subcutaneous (sc) insulin treatment + basal insulin treatment (comparator group) in subjects with type 1 diabetes previously treated with a basal/prandial regimen.; Secondary Objective: The secondary objectives of this clinical trial are to: 1. Evaluate the safety of T/I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events (AEs) and pulmonary function tests (PFTs); 2. Compare the area under the curve (AUC) postprandial venous plasma glucose values following a standardized liquid meal from 0-360 minutes; 3. Evaluate the proportion of subjects with HbA1c = 6.5%, = 7.0%, and = 8.0%; 4. Evaluate changes in the SF-36 Quality of Life (QoL) instrument between treatment groups; and, 5. Evaluate changes from the Insulin Treatment Questionnaire (ITQ) between treatment groups. ;Primary end point(s): The primary endpoint is to compare the mean change from baseline to Week 52 in HbA1c values between treatment groups.

—

Countries

Spain, United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026