Comparison of Insulin Detemir Produced by the Current Process and the NN729 Process in Healthy Subjects

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01490099

2006-001677-17 (EudraCT Number)

EX1729-1784

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to demonstrate bioequivalence between insulin detemir produced by the NN729 process and by the current process in healthy subjects.

Enrollment: 37 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body mass index (BMI) between 18.0 and 27.0 kg/m^2, inclusive
• Non-smoker
• Fasting plasma glucose (FPG) maximum 6.0 mmol/L

Exclusion criteria

• Known or suspected allergy to trial products or related products
• Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 months, sterilisation, the oral contraceptive pill (which should have been taken without difficulty for at least 3 months) or an approved hormonal implant)
• A history of alcohol or drug abuse

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 2 patient groups

Treatment period 1

Experimental group

Treatment:

Drug: insulin detemir

Treatment period 2

Active Comparator group

Treatment:

Drug: insulin detemir