Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in Type 2 Diabetes

Assessment of Safety and Efficacy of Biphasic Human Insulin IU 100 to EX1000 on Glycaemic Control in Subjects With Type 2 Diabetes

This trial is conducted in Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.

Inclusion Criteria:

• Type 2 diabetes for at least 12 months
• Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
• Body Mass Index (BMI) less than or equal to 40.0 kg/m2
• HbA1c less than or equal to 9.5%
• FPG (SMPG) less than or equal to 12 mmol/L

Exclusion Criteria:

• Treatment with more than 1IU/kg insulin daily
• Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
• 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