Skip to main content
OpenTrials
Completed

NCT Number: NCT01704378

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novo Nordisk Investigational Site, Kotka, Finland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biphasic insulin aspart

Drug

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

Primary outcomes

  1. Number of Hypoglycaemic episodes

  2. Occurrence of adverse events

Secondary outcomes

  1. HbA1c (glycosylated haemoglobin)

  2. Prandial increment in blood glucose

  3. 7-point blood glucose profile

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi-National, Multi-Centre, Open-Labelled Extension Study Assessing the Long-Term Safety of Biphasic Insulin Aspart 30 in NovoMix®30 FlexPen™ in Type 2 Diabetic Patients Previously Treated in BIAsp-1236

Important dates

Study start
2001
Primary completion
2003
Study completion
2003
First posted
Oct 11, 2012
Registry last updated
Feb 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.