Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir; Drug: insulin NPH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01497600

NN304-1439

Details and patient eligibility

About

This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
• Duration of diabetes at least 12 months
• Body Mass Index (BMI) below 33 kg/m^2
• HbA1c maximum 10 % based on analysis from the central laboratory

Exclusion criteria

• Current treatment with insulin above 1.2 U/kg/day
• Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
• Blood donation of more than 500 mL within the last three months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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50 participants in 2 patient groups

insulin detemir

Experimental group

Treatment:

Drug: insulin NPH

Drug: insulin detemir

insulin NPH

Active Comparator group

Treatment:

Drug: insulin NPH

Drug: insulin detemir