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Completed

NCT Number: NCT00834262

Observational Study on Safety and Efficacy of Biphasic Insulin Aspart in Type 2 Diabetes Patients

This study is conducted in Asia. The aim of this observational study is to evaluate the safety profile and clinical effectiveness of using various pre-mixes of Biphasic Insulin Aspart under routine clinical practice conditions in Israel in Type 2 Diabetes patients.

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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

Novo Nordisk Investigational Site

Kfar Saba, 44425, Israel

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Any patient with type 2 diabetes who has HbA1c greater than 7% on insulin with or without OAD and who needs intensification of treatment with either NovoMix® 30 or NovoMix® 50 or NovoMix® 70 or combinations, will be eligible

Exclusion criteria

  • Subjects with a hypersensitivity to biphasic insulin aspart or to any of the excipients. Particular attention should be paid to the drug interactions that are listed within the product local label.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within the next 12 months.

Treatment and study plan

biphasic insulin aspart 30

Drug

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Other names: NovoMix® 30

biphasic insulin aspart 50

Drug

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

biphasic insulin aspart 70

Drug

Dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation

Primary outcomes

  1. Number of all hypoglycaemic episodes

    Time frame: during 13 weeks of treatment

Secondary outcomes

  1. Number of adverse drug reactions

    Time frame: during 13 weeks of treatment

  2. Number of adverse events

    Time frame: during 13 weeks of treatment

  3. Number of all major hypoglycaemic (daytime and nocturnal) episodes

    Time frame: during 13 weeks of treatment

  4. Number of all minor and symptomatic (daytime and nocturnal) hypoglycaemic episodes

    Time frame: during 13 weeks of treatment

  5. Number of major hypoglycaemic episodes related to omission of a meal after injection

    Time frame: during 13 weeks of treatment

  6. Number of major hypoglycaemic episodes related to physical exercise of at least 30 min duration

    Time frame: during 13 weeks of treatment

  7. Weight (BMI) change

    Time frame: at the end of the study after 13 weeks of treatment

  8. HbA1c change

    Time frame: at the end of the study after 13 weeks of treatment

  9. Percentage of patients reaching the target of HbA1c of 7.0% or less

    Time frame: at the end of the study after 13 weeks of treatment

  10. Variability in fasting blood glucose values and average (mean) fasting blood glucose level

    Time frame: at the end of the study after 13 weeks of treatment

  11. Average post-breakfast (2h), post-lunch (2h), post-dinner (2h) blood glucose level

    Time frame: at the end of the study after 13 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Multi Centre, Open Label, Non-Randomized, Non Interventional, Observational Study on the Safety and Efficacy of Biphasic Insulin Aspart (NovoMix® 30, NovoMix® 50 and NovoMix® 70 or Combinations) in Type 2 Diabetes Mellitus Patients

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 3, 2009
Registry last updated
Oct 31, 2016

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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