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OpenTrials
Completed

NCT Number: NCT00671008

Observational Study of Patients Using NovoMix® 30 or Levemir® for Treatment of Type 1 or Type 2 Diabetes

This trial is conducted in Europe.

The aim of this observational study is to evaluate the glycaemic control in patients with type 1 or 2 diabetes using NovoMix® 30 or Levemir® under normal clinical practice conditions.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sarajevo, Bosnia and Herzegovina

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with Type 1 or Type 2 diabetes, including newly diagnosed
  • Age: Levemir® above 6 years
  • Age: Novomix® above 18 years

Exclusion criteria

  • Current treatment with NovoMix® 30 or Levemir®

Treatment and study plan

biphasic insulin aspart 30

Drug

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

Other names: NovoMix® 30

insulin detemir

Drug

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

Primary outcomes

  1. Glycaemic control as measured by HbA1c

    Time frame: After 24 weeks

Secondary outcomes

  1. Percentage of subjects to reach HbA1c below 7.0% and =6.5%

    Time frame: After 24 weeks

  2. Percentage of subjects on once vs twice daily injections of Levemir® or NovoMix® 30

    Time frame: After 24 weeks

  3. The effect on glycamic control as measured by FPG

    Time frame: After 24 weeks

  4. The effect on glycamic control as measured by PG profile

    Time frame: After 24 weeks

  5. Change in body weight

    Time frame: After 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy of Glycaemic Control of Biphasic Insulin Aspart (NovoMix® 30) or Insulin Detemir (Levemir®) in Patients With Type 1 or 2 Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 2, 2008
Registry last updated
Jan 2, 2024

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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