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Completed

NCT Number: NCT00775736

Observational Study Evaluating the Safety of NovoMix® in Type 2 Diabetes Patients Previously Treated With a Human Premix Insulin

This study is conducted in Europe. The objective of this observational study is to evaluate the number of serious side effects, when initiating NovoMix® treatment in patients with type 2 diabetes who previously used a human premix insulin under normal clinical practice

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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, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes mellitus

Exclusion criteria

  • Known or suspected allergy to study product or related products.
  • Pregnancy or breastfeeding or intention of becoming pregnant within the next 6 months.

Treatment and study plan

biphasic insulin aspart 30

Drug

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

Other names: BIAsp

biphasic insulin aspart 50

Drug

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

biphasic insulin aspart 70

Drug

Start dose and frequency and safety data collection at the discretion of the physician following clinical practice

Primary outcomes

  1. The number of serious adverse drug reactions, including major hypoglycaemic episodes, reported during the study period.

    Time frame: At baseline, 12 and 26 weeks.

Secondary outcomes

  1. Number of all hypoglycaemic episodes.

    Time frame: At baseline, 12 and 26 weeks.

  2. Number of all adverse drug reactions.

    Time frame: At baseline, 12 and 26 weeks.

  3. HbA1c

    Time frame: at 12 and 26 weeks

  4. Evaluation of fasting plasma glucose (FPG) values and postprandial glucose (PPG) levels

    Time frame: at 12 and 26 weeks

  5. Weight changes

    Time frame: at 12 and 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study Evaluating Safety in Patients With Type 2 Diabetes Treated With NovoMix® 30 or NovoMix® 50 or NovoMix®70 (Biphasic Insulin Aspart)

Acronym: Mix2Mix

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 20, 2008
Registry last updated
Jan 11, 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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