Safety and Efficacy of Inhaled Pre-Prandial Human Insulin in Type 2 Diabetes

Condition(s) targeted: Diabetes Mellitus, Type 2

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

Phase: Phase 3

Status: Terminated

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Line Elmoe Glesner, Study Director, Affiliation: Novo Nordisk A/S

This trial is conducted in Asia, Europe and Oceania.

The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to glimepiride for the treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects)

Official title: Safety and Efficacy of Inhaled Pre-Prandial Human Insulin Plus Glimepiride Versus Rosiglitazone Plus Glimepiride in Type 2 Diabetes

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

Primary outcome: Treatment difference in HbA1c

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 OAD(s) for more than or equal to 2 months

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

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

OAD monotherapy

- HbA1c greater than or equal to 7. 5 % and less than or equal to 10. 0 % for subjects on

OAD combination therapy

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

Canberra, Australia

Zagreb, Croatia

Royapuram, India

Skopje, Macedonia, The Former Yugoslav Republic of

Cebu City, Philippines

Moscow, Russian Federation

Bursa, Turkey

Clinical Trials at Novo Nordisk

Starting date: October 2006
Ending date: January 2008
Last updated: February 5, 2008