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

• Status: Completed
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

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%.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mannkind Corporation
• Treatments: Insulin; Insulin, Globin Zinc; Insulin, Short-Acting

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