Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin detemir; Drug: insulin aspart; Drug: inhaled human insulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00322257

NN1998-2076

Details and patient eligibility

About

This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.

Full description

The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.

Enrollment: 596 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 diabetes
• HbA1c less than or equal to 11%
• Body mass index (BMI) less than or equal to 40.0 kg/m2

Exclusion criteria

• Total daily insulin dosage more than 100 IU or U/day.
• Current smoking or smoking within the last 6 months
• Impaired hepatic or renal function
• Cardiac problems
• Uncontrolled hypertension
• Current proliferative retinopathy or maculopathy requiring acute treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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596 participants in 2 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

Drug: insulin detemir

B

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin detemir