Status:
COMPLETED
Safety and Efficacy of Biphasic Human Insulin Compared to EX1000 in 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 Asia and Africa. This trial aims for a comparison of blood glucose control of biphasic human insulin 100 IU/mL and EX1000.
Eligibility Criteria
Inclusion
- Type 2 diabetes for at least 12 months
- Current biphasic human insulin (BHI) for at least 3 months - as monotherapy or as the only insulin in combination with OADs
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 9.5%
- FPG (SMPG) less than or equal to 12 mmol/L
Exclusion
- Treatment with more than 1IU/kg insulin daily
- Treatment with Glucagon-like peptide 1 mimetics or dipeptityl peptidase IV inhibitors
- 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 :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
397 Patients enrolled
Trial Details
Trial ID
NCT00698802
Start Date
June 1 2008
End Date
March 1 2009
Last Update
April 14 2015
Active Locations (3)
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1
Vijayawada, India, 520002
2
Johannesburg, Gauteng, South Africa, 2193
3
Abu Dhabi, United Arab Emirates, 51900