Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes

Phase 3TerminatedNCT00322257

Novo Nordisk A/S596 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

596

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

inhaled human insulinDRUG

Treat-to-target dose titration scheme, inhalation.

insulin detemirDRUG

Injection s.c., 50% of daily dose

insulin aspartDRUG

Treat-to-target dose titration scheme, injection s.c.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (96)

Outcomes

Primary Outcomes

HbA1c

Time frame: After 52 weeks

Secondary Outcomes

Body weight

Time frame: after 52 weeks

Antibodies

Time frame: after 52 weeks

Hypoglycemia

Time frame: For the duration of the trial

Insulin doses

Time frame: For the duration of the trial

Pulmonary Function

Time frame: For the duration of the trial

Fasting plasma glucose

Time frame: after 52 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.