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OpenTrials
Completed

NCT Number: NCT00670722

Observational Study on Blood Glucose Control in Patients With Diabetes Using Modern Insulin

This study is conducted in Europe. An observational study evaluating the blood glucose control in patients using a modern insulin: NovoRapid®, NovoMix® 30 or Levemir® for treatment of Type 2 diabetes mellitus in Czech Republic.

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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

Prague, 16000, Czechia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 2 diabetes
  • Current treatment with human soluble insulin, insulin NPH or premixed human insulin
  • The selection of the subjects will be at the discretion of the individual physician

Exclusion criteria

  • Current treatment with insulin aspart, insulin detemir or biphasic insulin aspart 30
  • Previous enrolment in this study
  • Hypersensitivity to insulin aspart, insulin detemir or biphasic insulin aspart 30 or to any of the excipients.
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months and considered to be treated by biphasic insulin aspart 30 or insulin detemir

Treatment and study plan

insulin aspart

Drug

Intervention at the discretion of the physician

Other names: NovoRapid®

insulin detemir

Drug

Intervention at the discretion of the physician

biphasic insulin aspart 30

Drug

Intervention at the discretion of the physician

Primary outcomes

  1. HbA1c after switch from human insulin to modern insulin treatment

    Time frame: After 24 weeks

Secondary outcomes

  1. Percentage of subjects to reach HbA1c below 7.0% and = 6.5% at approximately 12 weeks and 24 weeks of treatment

    Time frame: After 12 and 24 weeks

  2. Postprandial glycaemic control as measured by PPG

    Time frame: After 12 and 24 weeks

  3. Glucose variability as measured by FPG

    Time frame: After 12 and 24 weeks

  4. Insulin dose and number of injections

    Time frame: After 12 and 24 weeks

  5. Body weight

    Time frame: After 12 and 24 weeks

  6. Number of hypoglycaemic events

    Time frame: During treatment

  7. Number of adverse drug reactions (ADR)

    Time frame: After 12 and 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational Study on Evaluation of Glycaemic Control in Patients Using a Modern Insulin - NovoRapid® (Insulin Aspart), NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 2, 2008
Registry last updated
Oct 28, 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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