Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

Novo Nordisk A/S15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

insulin NPHDRUG

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Novo Nordisk Investigational Site

Graz, Germany

Outcomes

Primary Outcomes

Area under the glucose infusion rate curve

Secondary Outcomes

Maximum glucose infusion rate

Time to maximum glucose

Area under the curve

Maximum concentration

Time to maximum concentration

Insulin clearance

Mean residence time of insulin

Terminal rate constant

Terminal half-life

Data from ClinicalTrials.gov

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