A four year, safety and tolerability, open-label, 'follow on' trial evaluating Technosphere®/Insulin in subjects with type 2 diabetes mellitus.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-001179-21-CZ

Enrollment

300

Registered

2004-11-03

Start date

2005-01-03

Completion date

Unknown

Last updated

2012-05-01

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

Conditions

To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in subjects with type 2 diabetes. MedDRA version: 9.1 Level: PT Classification code 10012601 Term: Diabetes mellitus

Interventions

Product Name: Technosphere®/Insulin Inhalation System Product Code: 193.003

193.004

193.007

193.008 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Human Insulin CAS Number: 11061-68-0 Concentration unit: IU/mg international unit(s)/milligram Concentration type: equal Concentrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Previous completion of PDC-INS-0008 or MKC-TO-005. 2. Subjects must be able to attend all scheduled visits and, in the opinion of the Investigator, be able to complete this safety trial. 3. Written informed consent. 4. Subjects must be able to understand English or have access to validated primary language trial documents. 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: 1. Clinically significant adverse events that remain unresolved from the previous trial and/or clinically significant abnormal laboratory values which are determined by the Investigator or the MKC Medical Monitor to be unsafe or confounding to continued participation. 2. Drug or alcohol dependency. 3. Smokers 4. Known hypersensitivity to the trial drug or to drugs of similar chemical structure 5. Anaemia 6. Evidence of moderate or greater ketones in urine 7. Women who are pregnant 8. Women of child-bearing potential practising inadequate birth control.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in subjects with type 2 diabetes who have previously completed enrolment in one of the following MannKind Corporation clinical trials; PDC-INS-0008(being conducted in the United states) or MKC-TI-005 (being conducted in Bulgaria, Czech Republic, Germany, and The Netherlands), utilizing serial pulmonary function testing and imaging.;Secondary Objective: The evaluate general safety and tolerability; to include: general safety measures, glucose control, marks of immune tolerance, haematology parameters, blood chemistry and Quality of Life (QOL) assessments in subjects receiving inhaled Technosphere®/Insulin.;Primary end point(s): 1. Pulmonary function tests ( spirometry and DLCO) 2. HRCT	—

Measure

Time frame

Main Objective: To evaluate the safety and tolerability of inhaled Technosphere®/Insulin in subjects with type 2 diabetes who have previously completed enrolment in one of the following MannKind Corporation clinical trials; PDC-INS-0008(being conducted in the United states) or MKC-TI-005 (being conducted in Bulgaria, Czech Republic, Germany, and The Netherlands), utilizing serial pulmonary function testing and imaging.;Secondary Objective: The evaluate general safety and tolerability; to include: general safety measures, glucose control, marks of immune tolerance, haematology parameters, blood chemistry and Quality of Life (QOL) assessments in subjects receiving inhaled Technosphere®/Insulin.;Primary end point(s): 1. Pulmonary function tests ( spirometry and DLCO) 2. HRCT

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Countries

Czech Republic, Germany

Outcome results

None listed

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