Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes

Assessment of Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation on Glycaemic Control in Subjects With Type 2 Diabetes

This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.

Inclusion Criteria:

• Type 2 diabetes for at least 12 months
• Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
• Body Mass Index (BMI) less than or equal to 40 kg/m2
• HbA1c less than or equal to 9.5%
• FPG less than or equal to 12 mmol/L

Exclusion Criteria:

• Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
• Treatment with more than 1 IU/kg NPH insulin daily
• Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
• Known or suspected allergy to trial products or related products
• Receipt of any investigational drug within one month prior to this trial
• Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers