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Completed

NCT Number: NCT01548235

Observational Safety Study in Subjects With Type 2 Diabetes Mellitus Starting or Switching to Biphasic Insulin Aspart 30 Treatment

This study is conducted in Europe. The aim of this study is to investigate safety and efficacy in subjects with type 2 diabetes mellitus starting or switching to biphasic insulin aspart 30 (NovoMix® 30) treatment.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Copenhagen S, 2300, Denmark

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Subjects with type 2 diabetes

Treatment and study plan

biphasic insulin aspart 30

Drug

Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.

Primary outcomes

  1. Incidence of SADR (serious adverse drug reactions) including major hypoglycaemia

Secondary outcomes

  1. Change from baseline in HbA1c (glycosylated haemoglobin)

  2. Mean FPG (fasting plasma glucose)

  3. Overall, daytime and nocturnal frequency of hypoglycaemic events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multicentre, Open Label, Non-randomised, Non-interventional, Observational Safety Study in Subjects With Type 2 Diabetes Mellitus, Starting or Switching to NovoMix® 30 Treatment

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Mar 8, 2012
Registry last updated
Jan 6, 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.

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