Glycaemic Control of Biphasic Insulin Aspart 70 and 30 in Subjects With Type 2 Diabetes

Novo Nordisk A/S31 enrolled

Overview

This trial is conducted in Europe. The aim of this trial is to compare the glycaemic control of biphasic insulin aspart 70 + biphasic insulin aspart 30 with biphasic human insulin 30 in subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period

biphasic insulin aspart 70DRUG

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period

biphasic human insulin 30DRUG

Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with Type 2 diabetes * Treatment with BHI (biphasic human insulin) 30 twice daily for at least three months * HbA1c maximum 10.0% * BMI (Body Mass Index) maximum 35.0 kg/m2 * Able and willing to perform self-blood glucose monitoring (SBGM) Exclusion Criteria: * The receipt of any investigational drug within the last 30 days prior to this trial * Total daily insulin dose minimum 2.0 U/(kg·day) * A history of drug abuse or alcohol dependence within the last 5 years * Impaired hepatic function * Impaired renal function * Cardiac disease * Severe, uncontrolled hypertension

Locations (1)

Novo Nordisk Investigational Site

Newcastle, United Kingdom

Outcomes

Primary Outcomes

Glucose average in 24-hour blood glucose profiles

Secondary Outcomes

Pre-meal glucose level

Post-meal excursion of glucose (0-4 hours)

Cmax, maximum concentration of total insulin

tmax, time of maximum concentration of total insulin

The area under the 24-hour total insulin concentration time curve

Adverse events

Data from ClinicalTrials.gov

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