Glycemic Control of Biphasic Insulin Aspart 30 in Type 2 Diabetes

Novo Nordisk A/S131 enrolled

Overview

This this trial is conducted in Europe. The aim of this trial is to compare glycaemic control of biphasic insulin aspart 30 (BIAsp 30) alone or combined with insulin aspart(IAsp) in patients previously treated with conventional Biphasic Human Insulin 30/70.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

131

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspart 30DRUG

Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals

insulin aspartDRUG

Administrated subcutaneously (s.c., under the skin) before lunch

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Current treatment with conventional biphasic human insulin 30/70 b.i.d. (twice daily) for at least 3 months * HbA1c (glycosylated haemoglobin) equal to or below 12% * Willing and able to perform self blood glucose monitoring (SMBG) Exclusion Criteria: * History of drug or alcohol dependence * Mental incapacity, unwillingness or language barriers precluding adequate understanding or co-operation * Previous participation in this trial * Receipt of any investigational drug within the last month prior to this trial * Known or suspected allergy to trial products or related products

Locations (12)

Novo Nordisk Investigational Site

Bialystok, Poland

Novo Nordisk Investigational Site

Bytom, Poland

Novo Nordisk Investigational Site

Kamieniec Ząbkowicki, Poland

Outcomes

Primary Outcomes

HbA1c (glycosylated haemoglobin)

Secondary Outcomes

7-point blood glucose profile

Correlation of endpoint HbA1c with baseline BMI (body mass index) and HbA1c with treatment mode stratification

Incidence of adverse events

Hypoglycaemic episodes (minor, major or nocturnal)

Data from ClinicalTrials.gov

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