Within-subject Variability of Insulin Detemir in Healthy Volunteers

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin glargine; Drug: insulin detemir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497535

NN304-1438

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to compare the within-subject variability of insulin detemir to that of another basal insulin analogue, insulin glargine in healthy volunteers.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Healthy Japanese men or women
• Holding a Japanese pass-port and Japanese-born parents
• Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator
• Body Mass Index (BMI) between 18 and 30 kg/m^2, incl.
• Fasting blood glucose maximum 6 mmol/L

Exclusion criteria

• Clinically significant abnormal haematology or biochemistry screening tests, as judged by the Investigator
• Any serious systemic infectious disease that occurred during the four weeks prior to the first dose of the trial product, as judged by the Investigator
• Subject with history of alcohol or drug dependence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups

Insulin detemir

Experimental group

Treatment:

Drug: insulin detemir

Insulin glargine

Active Comparator group

Treatment:

Drug: insulin glargine