Safety of Insulin Detemir Produced by a New Process as Measured by Antibody Formation in Subjects With Type 1 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes Mellitus, Type 1; Diabetes

Treatments: Drug: insulin aspart; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT00447382

EX1729-1778

2006-004733-15 (EudraCT Number)

Details and patient eligibility

About

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 production method (NN729) with insulin detemir made by the previous production method (NN304). Subjects were treated with NN729 or NN304 for a period of 52 weeks at the same total daily dose and frequency of administration as their own pre-trial basal insulin . During the trial doses were individualised based on subject's plasma glucose measurements.

Enrollment: 330 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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330 participants in 2 patient groups

NN304

Active Comparator group

Description:

Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin detemir

NN729

Experimental group

Description:

Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks

Treatment:

Drug: insulin aspart

Drug: insulin detemir

Drug: insulin detemir