Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes

Novo Nordisk

Status and phase: Terminated; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00331604

2005-005378-58 (EudraCT Number)

NN1998-2161

Details and patient eligibility

About

This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin detemir in Type 2 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: 618 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Currently treated with insulin
• Body mass index of (BMI) less than or equal to 40.0 kg/m2
• HbA1c less than or equal to 11.0%

Exclusion criteria

• Total daily insulin dosage less than or equal to 100 IU or U/day
• Current smoking or smoking within the last 6 months
• Cardiac problems
• Uncontrolled hypertension
• Current proliferative retinopathy or maculopathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

618 participants in 3 patient groups

A

Experimental group

Treatment:

Drug: inhaled human insulin

Drug: insulin detemir

B

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin aspart

C

Active Comparator group

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin aspart