Status:
COMPLETED
Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The trial was conducted in Germany, The Republic of Macedonia, Russian Federation, Serbia and South Africa. The aim of this trial was to make a safety comparison of insulin detemir produced by a new p...
Eligibility Criteria
Inclusion
- Type 1 diabetes for at least 12 months
- Basal-bolus treatment for at least 3 months
- Body Mass Index (BMI) less than or equal to 35.0 kg/m\^2
- HbA1c (glycosylated haemoglobin) less than or equal to 12.0%
Exclusion
- Known or suspected allergy to trial products or related products
- Pregnancy, breast-feeding or the intention to become pregnant or not using adequate contraceptive measures
- Receipt of any trial drug within 1 month prior to this trial
- Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
- Conditions that may interfere with trial participation as judged by Investigator: proliferative retinopathy or maculopathy requiring acute treatment within the last six months, recurrent major hypoglycaemia, impaired hepatic or renal function, cardiac problems, uncontrolled hypertension (treated and untreated)
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT00447382
Start Date
March 1 2007
End Date
July 1 2008
Last Update
January 2 2024
Active Locations (5)
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1
Frankfurt, Germany, 60590
2
Skopje, North Macedonia, 1000
3
Moscow, Russia, 119034
4
Belgrade, Serbia and Montenegro, 11000