Efficacy and Safety of Biphasic Insulin Aspart 30 With Metformin in Type 2 Diabetes
Status and phase
Completed
Phase 4
Conditions
Diabetes
Diabetes Mellitus, Type 2
Treatments
Drug: metformin
Drug: biphasic insulin aspart
Details and patient eligibility
About
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.
Enrollment
140 patients
Sex
All
Ages
18 to 99 years old
Volunteers
No Healthy Volunteers
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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
15
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Data sourced from clinicaltrials.gov
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