Status:
COMPLETED
Safety and Efficacy of Insulin NPH Compared to a New Insulin Formulation in Subjects With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is conducted in South America. This trial aims for a comparison of the safety and efficacy of insulin NPH and a new insulin formulation on blood glucose control.
Eligibility Criteria
Inclusion
- Type 2 diabetes for at least 12 months
- Current NPH treatment for at least 3 months - alone or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40 kg/m2
- HbA1c less than or equal to 9.5%
- FPG less than or equal to 12 mmol/L
Exclusion
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- Treatment with more than 1 IU/kg NPH insulin daily
- Known hypoglycaemia unawareness or recurrent major hypoglycaemia, as judged by the Investigator
- Known or suspected allergy to trial products or related products
- Receipt of any investigational drug within one month prior to this trial
- Any other condition that the Investigator feels would interfere with trial participation or evaluation of results, e.g. shiftworkers
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
402 Patients enrolled
Trial Details
Trial ID
NCT00660374
Start Date
February 1 2008
End Date
March 1 2009
Last Update
May 5 2015
Active Locations (1)
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1
Salvador, Brazil, 40420-000