Diabetes Type 2
Conditions
Brief summary
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%.
Interventions
Sponsors
Mannkind Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in HbA1c from baseline to treatment week 24 | 24 weeks |
Countries
Russia
Outcome results
None listed