Status:
COMPLETED
Effect of Biphasic Insulin Compared to Biphasic Insulin Combined With Insulin Aspart, With or Without Metformin in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-18 years
Phase:
PHASE4
Brief Summary
This trial is conducted in Africa and Middle East. The objective of the study is to compare glycemic control of Biphasic insulin Aspart 30 twice daily with Biphasic insulin Aspart 30 twice daily plus ...
Eligibility Criteria
Inclusion
- Type 2 diabetic subjects
- Current treatment with Biphasic Human Insulin 30/70 twice daily alone or in combination with any oral hypoglycaemic agent for at least 3 months prior to entering the trial
- HbA1c at least 12%
- Willing and able to perform self blood glucose monitoring (SMBG)
Exclusion
- History of drug or alcohol dependence
- Receipt of any investigational drug within the last month prior to this trial
- Anticipated change in dose of prescription medication, which may influence glucose regulation (Mono Amino Oxidase-inhibitors, non selective beta-adrenergic agents, anabolic steroids and systemic glucocorticoids)
- Severe uncontrolled hypertension
- Recurrent severe hypoglycemia as judged by investigator
- Any disease or condition, which the Investigator feels, would interfere with the trial
Key Trial Info
Start Date :
February 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00282451
Start Date
February 1 2006
End Date
August 1 2006
Last Update
October 31 2016
Active Locations (4)
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1
Novo Nordisk Investigational Site
Aghakhan, Egypt
2
Novo Nordisk Investigational Site
Giza, Egypt
3
Novo Nordisk Investigational Site
Jeddah, Saudi Arabia, 80215
4
Novo Nordisk Investigational Site
Riyadh, Saudi Arabia, 245