Overview

Comparison of Biphasic Insulin Aspart 30 Twice Daily With Two Different Initial Dosage Split Regimens in Subjects With Type 2 Diabetes: An Extension to Trial BIASP-3756

Status:
Completed
Trial end date:
2011-09-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Asia. The aim of the trial is to compare the effect on glycaemic control of biphasic insulin aspart 30 twice daily with two different dosage split regimens for Chinese subjects with type 2 diabetes who did not achieve the treatment target of a glycosylated haemoglobin A1c (HbA1c) below 7% in trial BIASP-3756 (NCT01123980).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Biphasic Insulins
Insulin
Insulin Aspart
Insulin aspart, insulin aspart protamine drug combination 30:70
Insulin degludec, insulin aspart drug combination
Insulin Glargine
Insulin, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Metformin
Criteria
Inclusion Criteria:

- Finalised 24 weeks of treatment with once daily BIAsp 30 or insulin glargine in
combination with metformin and glimepiride in trial BIAsp-3756

- HbA1c above or equal to 7.0%

- Body Mass Index (BMI) below or equal to 40.0 kg/m2

Exclusion Criteria:

- Known hypoglycaemia unawareness or recurrent major hypoglycaemic episodes in trial
BIAsp-3756

- Known proliferative retinopathy or maculopathy requiring acute treatment

- Any disease or condition which the Investigator (trial physician) feels would
interfere with the trial