Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00539890
• Date of registration: 03/10/2007
• Prospective Registration: No
• Primary sponsor: Mannkind Corporation
• Public title: Comparison Between Technosphere/Insulin Inhalation Powder Versus Rapid Acting Insulin in Subjects With Type 2 Diabetes Mellitus
• Scientific title: A Phase 3 Randomized, Open Label, Multi-Center Comparative Study of Technosphere /Insulin Versus Rapid Acting Insulin in Subjects With Type-2 Diabetes Mellitus Receiving Lantus as Basal Insulin
• Date of first enrolment: November 2005
• Target sample size: 0
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00539890
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Russian Federation

Contacts

• Name: Robert Baughman, PhD
• Affiliation: Mannkind Corporation

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 2 years since diagnosis of type 2 diabetes mellitus

- Received subcutaneous (sc) insulin for at least 3 months

- Body Mass Index <44 kg/m2

- HbA1c>7.0% and <11.5%

- Serum creatinine <2.0 mg/dL for males and <1.8 mg/dL for females

- Baseline FVC and FEV1>70% and < 125% of predicted normal

Exclusion Criteria:

- Significant hepatic disease (AST/ALT3 x ULN)

- Diagnosis of Type 1 diabetes

- Severe complications of diabetes

- History of moderate to severe ketoacidosis within the past 3 months

- Upper respiratory infection in the last 15 days or a lower respiratory infection in
the past 30 days

- Diagnosis of HIV

- Positive serology for hepatitis B or C

- COPD, emphysema, or asthma

- Current smokers or smoking history within the past 6 months

- Major psychiatric disorder precluding satisfactory completion of protocol

- Clinically significant heart disease disease, stroke or heart attack within the past
6 months

- Treatment with an investigational drug within 30 days

- Previous treatment with Technosphere/Insulin

- History of malignancy in the past 5 years except basal cell carcinoma

- Anemia (hemoglobin <10.5 g/dL for females and <11.5 g/dL (for males)

- Women who were pregnant of lactating

- History of hypersensitivity to drugs resembling FDKP carrier products

- Treatment with another inhaled insulin product during the duration of the study



Age minimum: 18 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Type 2

Intervention(s)

Drug: Technosphere Insulin

Primary Outcome(s)

Mean change in HbA1c from baseline to treatment week 24 [Time Frame: 24 weeks]

Secondary ID(s)

MKC-TI-014

Source(s) of Monetary Support

Please refer to primary and secondary sponsors