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

Condition(s) targeted: Diabetes Mellitus, Type 2

Intervention: Rosiglitazone (Drug); Metformin (Drug); Inhaled pre-prandial human insulin (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Novo Nordisk

Official(s) and/or principal investigator(s):
Pernille Johansen, BSc, Study Director, Affiliation: Novo Nordisk A/S

Overall contact:
Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

This trial is conducted in Europe.

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

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

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

Primary outcome: Treatment difference in HbA1c after 26 weeks

Secondary outcome:

Adverse events

body weight

Lung function

Blood glucose

Hypoglycaemia

Minimum age: 18 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Type 2 diabetes

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

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

- HbA1c greater than or equal to 7. 5% and less than or equal to 11. 0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7. 0% 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 disorders

- Uncontrolled hypertension

- Proliferative retinopathy or maculopathy

Public Access to Clinical Trials - Novo Nordisk, Phone: Please Contact NN via email, Email: clinicaltrials@novonordisk.com

Uniklinik für Innere Medizin III, Vienna, Austria; Recruiting

Tapani Rönnemaa, Sisätautien Klinikka, Turku, Finland; Recruiting

John Nolan, Dublin, Ireland; Recruiting

Pierre Serusclat, Paris, France; Recruiting

Ziekenhuis Bronovo, Den Haag, Netherlands; Recruiting

Stoffwechselzentrum Hirslanden, Zürich, Switzerland; Recruiting

Jürgen Schmidt, Flörsheim, Germany; Recruiting

Singleton Hospital, Swansea, United Kingdom; Recruiting

Hospital Universitario de San Juan, San Juan de Alicante (Alicante), Spain; Recruiting

Starting date: November 2006
Last updated: November 1, 2006