Efficacy and Safety of Biphasic Insulin Aspart 30 FlexPen™ in Subjects With Type 2 Diabetes

Novo Nordisk A/S89 enrolled

Overview

This trial is conducted in Europe. The aim of this trial investigate the the long-term safety of biphasic insulin aspart 30 in subjects with type 2 diabetes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

biphasic insulin aspartDRUG

Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Signed informed consent obtained before any trial-related activities * Completed the trial BIAsp-1236 Exclusion Criteria: * Planned changes in use of any prescription medication that may interfere with glucose regulation * Known or suspected allergy to trial products or related products * Women who are having the intention of becoming pregnant, or are judged not to be using adequate contraceptive measures * Any other significant condition or concomitant disease or any condition that would interfere with participation as judged by the Investigator

Locations (17)

Novo Nordisk Investigational Site

Kotka, Finland

Novo Nordisk Investigational Site

Kuopio, Finland

Outcomes

Primary Outcomes

Number of Hypoglycaemic episodes

Occurrence of adverse events

Secondary Outcomes

HbA1c (glycosylated haemoglobin)

Prandial increment in blood glucose

7-point blood glucose profile

Data from ClinicalTrials.gov

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