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OpenTrials
Completed

NCT Number: NCT00696995

An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

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

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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

Up to 99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Lahti, 15110, Finland

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Type 2 diabetes
  • Insulin-naive or previously treated by basal only insulin therapy

Exclusion criteria

  • Patients who are unlikely to comply with the protocol
  • Pregnancy or breastfeeding or intention of becoming pregnant

Treatment and study plan

biphasic insulin aspart 30

Drug

Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation

Other names: NovoMix® 30

Primary outcomes

  1. The number of serious adverse drug reactions, including major hypoglycaemic events

    Time frame: at 26 weeks

Secondary outcomes

  1. The number of all hypoglycaemic events

    Time frame: at 26 weeks

  2. HbA1c

    Time frame: at 12 weeks and 26 weeks

  3. Fasting plasma glucose at visits

    Time frame: at 12 weeks and 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment

Acronym: Start

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 13, 2008
Registry last updated
Jan 9, 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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