Efficacy & Safety of Inhaled Insulin in Type 1 Diabetes

MannKind

Status and phase: Completed; Phase 3

Conditions: Diabetes, Type I

Treatments: Drug: Technosphere Insulin; Drug: Active comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308308

MKC-TI-009

Details and patient eligibility

About

To determine the safety and efficacy of inhaled insulin in the treatment of type 1 diabetes

Enrollment: 589 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of type 1 diabetes for at least 1 year
• Nonsmokers for prior 6 months
• BMI less than or equal to 35kg/m2
• HbA1c > or = 7% and < or = 11%
• Serum creatinine < or = 1.8 mg/dL in female subjects and < or = 2.0 mg/dL in male subjects
• FEV1 > or = 70% of predicted, DLco > or = 70% , TLC > or = 80% predicted
• Maintenance of a treatment regimen of insulin less than or equal to 1.4 iu/kg/day
• Urine cotinine < or = 100 ng/mL

Exclusion criteria

• History of chronic obstructive pulmonary disease, asthma, any other clinically significant pulmonary disease confirmed by documented history, pulmonary function testing or radiologic findings
• Evidence of severe complications of diabetes
• Aminotransferase and/or alanine aminotransferase > than 3 times the upper limit of normal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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589 participants in 2 patient groups

1

Experimental group

Description:

Technosphere Insulin

Treatment:

Drug: Technosphere Insulin

2

Active Comparator group

Description:

Rapid-acting analogue insulin plus basal insulin glargine

Treatment:

Drug: Active comparator