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

• Status: Terminated
• Trial end date: 2008-04-24
• Target enrollment: 0
• Participant gender: All

Summary

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).

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

Details

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

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