Status:
COMPLETED
Efficacy and Safety of a Fixed or a Flexible Supplementary Insulin Therapy in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
This trial is conducted in Europe. This trial aims for a comparison of the efficacy and safety of Insulin Aspart, given in a fixed or in a flexible supplementary insulin therapy, with or without Insul...
Eligibility Criteria
Inclusion
- Type 2 Diabetes for more than 6 months
- Treatment with 1 or more oral anti-diabetic drugs or insulin, or a combination of these for more than 3 months
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- HbA1c 7.0-11.0%
Exclusion
- Treatment with short acting insulin(s) for longer than 10 days
- Current treatment with TZDs. A TZD medication must be stopped at least 14 days before the randomization
- Proliferative retinopathy or maculopathy requiring acute or laser treatment within the last 6 months
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2006
Estimated Enrollment :
373 Patients enrolled
Trial Details
Trial ID
NCT00274274
Start Date
September 1 2005
End Date
November 1 2006
Last Update
November 21 2014
Active Locations (1)
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1
Düsseldorf, Germany