A Prospective, Multi-Center, Open-Label, Randomized, Controlled Clinical Trial Comparing the Efficacy and Safety in Subjects With Type 2 Diabetes Receiving Subcutaneous Basal Insulin and Prandial Inhalation of Technosphere®/Insulin Versus Subcutaneous Premixed Insulin Therapy 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

EUCTR2006-000305-35-GB

Enrollment

668

Registered

2006-04-21

Start date

2006-06-23

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 II MedDRA version: 9.1 Level: PT Classification code 10012601 Term: Diabetes mellitus

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-smoking males and females >/= 18 and 7.0% and /= 70% predicted (NHANES III); DLco >/= 70% predicted (Miller) Total Lung Capacity >/= 80% predicted (ITS) 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: subjects receiving concomitant sulphonylureas, meglitinides, alpha glucosidase inhibitors, pramlintide acetate (Symlin®), and/or any incretins (eg, exenatides, such as Byetta®) within the preceding 8 weeks; history of viral and/or cirrhotic hepatic disease and/or abnormal liver enzymes (aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] >/= 3 times the upper limit of normal); 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, pulmonary function testing, or radiologic findings; or 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 change in HbA1c) over a 52-week period of prandial administration of Technosphere®/Insulin (T/I) in combination with basal insulin therapy (T/I group) versus a premix of intermediate acting and rapid acting insulin (comparator group) in subjects with subobtimally controlled type 2 diabetes treated with regimens of sc insulins plus or minus oral anti-hyperglycemic agents. ; Secondary Objective: • The secondary objectives are to: 1. Evaluate the safety of T/I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests. 2. Compare the 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) between treatment groups. 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 change in HbA1c) over a 52-week period of prandial administration of Technosphere®/Insulin (T/I) in combination with basal insulin therapy (T/I group) versus a premix of intermediate acting and rapid acting insulin (comparator group) in subjects with subobtimally controlled type 2 diabetes treated with regimens of sc insulins plus or minus oral anti-hyperglycemic agents. ; Secondary Objective: • The secondary objectives are to: 1. Evaluate the safety of T/I treatment by assessing clinical laboratory parameters, hypoglycemia, hyperglycemia, and other adverse events and pulmonary function tests. 2. Compare the 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) between treatment groups. 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.

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Countries

Spain, United Kingdom

Outcome results

None listed

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