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

• Status: Completed
• Trial end date: 2009-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

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