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Completed

NCT Number: NCT00704223

Observational Study to Evaluate the Safety and Efficacy of NovoMix® 70 in Type 2 Diabetes

This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of adverse events while using NovoMix® 70 under normal clinical practice conditions in Austria.

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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 and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vienna, 1140, Austria

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • HbA1c over 7%
  • No contraindication with NovoMix® 70

Exclusion criteria

  • Type 1 diabetes
  • Subjects participating in a clinical trial or another observational study
  • Subjects under previous basis-bolus insulin therapy
  • Women who are pregnant, breast feeding and women of child bearing capacity who are not using any reliable contraceptive method

Treatment and study plan

biphasic insulin aspart

Drug

Start dose and frequency to prescribed by the physician as a result of a normal clinical evaluation

Other names: NovoMix® 70

Primary outcomes

  1. number of major and minor hypoglycaemic events and adverse events

    Time frame: 3 months

Secondary outcomes

  1. HbA1c

    Time frame: 3 months

  2. PPBG

    Time frame: 3 months

  3. FBG

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study on Safety and Efficacy in Subjects Using NovoMix® 70 (Biphasic Insulin Aspart) for Treatment of Type 2 Diabetes Mellitus

Acronym: INTENSIV

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 24, 2008
Registry last updated
Jun 24, 2014

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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