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Completed

NCT Number: NCT01486875

Observational Study of Safety of NovoMix® 30 Treatment for Type 2 Diabetes

This trial is conducted in Europe. The aim of this trial is to evaluate the incidence of serious adverse drug reactions when initiating insulin therapy with NovoMix® 30 in subjects with type 2 diabetes mellitus under normal clinical practice conditions in Sweden.

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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

Age range

18 year–68 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Lund, 221 85, Sweden

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

Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs)

    Time frame: Week 26

  2. Incidence of major hypoglycaemic events

    Time frame: Week 26

Secondary outcomes

  1. Number of all hypoglycaemic events

    Time frame: In the 4 weeks prior to week 12 and week 26, respectively

  2. HbA1c (glycosylated haemoglobin A1c)

    Time frame: Week 26

  3. Fasting Plasma Glucose (FPG)

    Time frame: Week 26

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Acronym: Start

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Dec 7, 2011
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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