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

MannKind

Status and phase

Completed

Phase 3

Conditions

Diabetes Type 2

Treatments

Drug: Technosphere Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00539890

MKC-TI-014

Details and patient eligibility

About

To compare the efficacy of prandial TI plus basal insulin versus prandial rapid acting, subcutaneous insulin plus basal insulin in subjects with type 2 diabetes who had an HbA1c >7.0% and <11.5%.

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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