Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus

Intervention: inhaled human insulin (Drug); metformin (Drug); glimepiride (Drug); inhaled human insulin (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Dorthe Lyngsoe Vuylsteke, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy in treatment of subjects with type 2 diabetes and to verify the safety of use (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).

Official title: Efficacy and Safety of Inhaled Prandial Insulin Compared to Metformin Plus Glimepiride in Type 2 Diabetes

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: HbA1c change from baseline

Secondary outcome:

Adverse events

body weight

Lung function

Blood glucose

Hypoglycaemia

Detailed description: Detailed 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

- Treated with OADs for more than or equal to 3 months

- HbA1c greater than or equal to 8. 0% and less than or equal to 11. 0%

- Body Mass Index (BMI) less than or equal to 40. 0 kg/m2

Exclusion Criteria:

- Recurrent major hypoglycaemia

- Current smoking or smoking within the last 6 months

- Impaired hepatic or renal function

- Cardiac problems

- Uncontrolled hypertension

- Proliferative retinopathy or maculopathy

Buenos Aires, Argentina

Vienna, Austria

Leuven, Belgium

Sofia, Bulgaria

Novo Nordisk Clinical Trial Call Center, Edmonton, Canada

Narbonne, France

Hyderabad, India

Beer Sheva, Israel

Novo Nordisk Clinical Trial Call Center, Mexico City, Mexico

Gdansk, Poland

Istanbul, Turkey

Clinical Trials at Novo Nordisk

Starting date: May 2007
Ending date: January 2008
Last updated: February 5, 2008