Overview

Efficacy of Biphasic Insulin Aspart 30 in Subjects With Type 2 Diabetes Failing on OADs

Status:
Completed
Trial end date:
2006-07-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in North America. The aim of this trial is to investigate the efficacy of biphasic insulin aspart 30 in subjects with type 2 diabetes not achieving glycaemic targets on OADs (oral anti-diabetic drugs).
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, Globin Zinc
Insulin, Isophane
Insulin, Long-Acting
Criteria
Inclusion Criteria:

- Type 2 diabetes mellitus for at least 12 months

- HbA1c between 7.5-14.5% (inclusive) at screening

- Insulin naïve

- An antidiabetic regimen that has been stable for at least 3 months prior to screening

- An antidiabetic regimen that includes a minimum of 2 OADs

Exclusion Criteria:

- Use of any insulin preparations within the past 6 months

- Active proliferative retinopathy or maculopathy requiring treatment within 6 months
prior to screening