Pharmacodynamics and 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

NCT01497561

NN304-1538

Details and patient eligibility

About

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 2 diabetes
• Subjects treated with insulin for minimum 3 months
• Duration of diabetes for at least 12 months
• Body Mass Index (BMI) below 30 kg/m^2
• HbA1c maximum 10% based on analysis from central laboratory

Exclusion criteria

• Current treatment with insulin above 1.2 U/kg/day
• Current treatment with insulin glargine
• Current treatment with drugs known to interfere with glucose metabolism
• Current treatment with oral antidiabetic drugs

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 2 patient groups

insulin detemir

Experimental group

Treatment:

Drug: insulin detemir

insulin NPH

Active Comparator group

Treatment:

Drug: insulin NPH