Status:
COMPLETED
Comparing the Efficacy and Safety of Biphasic Insulin Aspart 30 and Biphasic Human Insulin 30 on Blood Sugar Control in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
This trial is conducted in Asia. The aim of this clinical trial is to investigate the blood sugar lowering effect and the safety profile of biphasic insulin aspart 30 compared to biphasic human insuli...
Eligibility Criteria
Inclusion
- Type 2 diabetes diagnosed for at least 6 months
- Insulin-naive (less than or equal to 1 week of daily use of insulin therapy)
- Treatment with metformin as monotherapy or in combination therapy with other OAD(s) for at least 3 months prior to this trial
- Currently on metformin greater than or equal to 1000 mg/day for at least 2 weeks
- Currently at least one of other OAD(s) reaching at least one-half of the recommended maximum dose for at least 2 weeks
- Glycosylated haemoglobin (HbA1c) between 7.5-11.0%
- Body Mass Index (BMI) between 18.5 - 35.0 kg/m\^2
- Be able and willing to perform continuous glucose monitoring system (CGMS ) and self-monitored blood glucose (SMBG)
Exclusion
- Known or suspected allergy to trial product(s) or related products
- Any contraindication of metformin
- Receipt of investigational drug within the last 3 months prior to this trial
- Any history of chronic insulin therapy (more than 1 week of daily use)
- Systemically treated with thiazolidinediones (TZDs) for more than one month within 6 months prior to this trial
- Pregnancy, nursing mother, or unwillingness to use adequate contraception
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
145 Patients enrolled
Trial Details
Trial ID
NCT00807092
Start Date
December 1 2008
End Date
October 1 2009
Last Update
March 4 2015
Active Locations (1)
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1
Beijing, Beijing Municipality, China, 100730