A 3 Month, Randomized, Open Label, Multi-center Study of Technosphere/Insulin Compared to Insulin Aspart in Subjects With Type 1 Diabetes Mellitus Receiving Insulin Glargine

MannKind

Status and phase: Completed; Phase 2

Conditions: Diabetes Mellitus, Type 1

Treatments: Drug: Technosphere Insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00539396

MKC-TI-101

Details and patient eligibility

About

A 3 month, randomized, open label, multi-center study of Technosphere/Insulin compared to insulin aspart in subjects with type 1 diabetes mellitus receiving insulin glargine

Enrollment: 110 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes currently receiving SC insulin at mealtimes for at least 3 months
• BMI <40 kg/m squared
• HbA1c greater than or equal to 7% and less than or equal to 11.5%
• Serum creatinine less than 2 for males and less than 1.8 for females
• Acceptable pulmonary function

Exclusion criteria

• Significant hepatic disease
• Previously diagnosed pulmonary disease, ketoacidosis of evidence of severe secondary complications of diabetes

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)