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

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

Conditions

Diabetes Mellitus, Type 2

Study Type

Interventional

Study Design

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

Further Details

Primary Outcome Measures:

• Treatment difference in HbA1c [Time Frame: After 26 weeks]

Secondary Outcome Measures:

• Adverse events
• body weight
• Lung function
• Blood glucose
• Hypoglycaemia

Study Start

October 2006

Eligibility & Criteria

• Ages Eligible for Study: 18 Years and above
• Genders Eligible for Study: Both

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

Total Enrolment

345

Contact Details

Australian Locations:

• Canberra, Australia; Recruiting

Contact NN via clinicaltrials@novonordisk.com or visit Novo Nordisk Trials