Pharmacokinetics, Pharmacodynamics and Safety of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk A/S13 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to investigate pharmacokinetics, pharmacodynamics and safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

biphasic human insulin 30DRUG

Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes for at least 12 months * Treated with a combination of soluble/protracted human insulin in the ratio of 30/70 in a twice-daily regimen for at least 6 months * BMI (body mass index) below 39 kg/m\^2 * HbA1c (glycosylated haemoglobin) below 12%

Locations (2)

Novo Nordisk Investigational Site

Alphen aan den Rijn, Netherlands

Novo Nordisk Investigational Site

Crawley, United Kingdom

Outcomes

Primary Outcomes

Area under the serum insulin curve

Secondary Outcomes

Overall shape of the 24 hour serum insulin profile

Cmax (maximum plasma concentration)

tmax (time to reach maximum)

Area under the curve following each injections derived from 24 hours serum insulin profiles

Overall shape of the 24 hour serum glucose profile

Serum glucose excursions (EXC)

Data from ClinicalTrials.gov

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