Status:
COMPLETED
Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-99 years
Phase:
PHASE4
Brief 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 i...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2005
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00624364
Start Date
May 1 2004
End Date
May 1 2005
Last Update
January 6 2017
Active Locations (15)
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1
Novo Nordisk Investigational Site
Bloemfontein, Free State, South Africa, 9301
2
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1827
3
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 1829
4
Novo Nordisk Investigational Site
Johannesburg, Gauteng, South Africa, 2001