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

• Status: Terminated
• Trial end date: 2008-03-05
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Insulin; Insulin, Globin Zinc; Metformin; Rosiglitazone

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