Overview

Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes

Status:
Completed
Trial end date:
2005-05-01
Target enrollment:
0
Participant gender:
All
Summary
This trial is conducted in Africa. The aim of this trial is to evaluate the efficacy and safety of biphasic insulin aspart plus OAD compared to biphasic insulin aspart alone on blood glucose control in type 2 diabetes.
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, Long-Acting
Metformin
Criteria
Inclusion Criteria:

- Type 2 diabetes

- Currently treated with maximum doses of any kind of OAD alone or any kind of oral
combination therapy for at least 2 months

- Body mass index (BMI) below 40.0 kg/m2

- HbA1c between 7.5-13.0%

Exclusion Criteria:

- History of drug or alcohol dependence

- Mental incapacity, unwillingness or language barriers precluding adequate

- Subjects previously screened to participation or having already participated in this
trial

- Receipt of any investigational drug within the last month prior to this trial

- Known or suspected allergy to trial products or related products