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OpenTrials
Completed

NCT Number: NCT00842894

Safety of NovoMix® 30 or Levemir® for Treatment of Type 2 Diabetics in Macedonia

This study is conducted in Europe. The aim of this observational study is to investigate the incidence of serious adverse drug reactions when using NovoMix® 30 (biphasic insulin aspart 30) or Levemir® (insulin detemir) for treatment of type 2 diabetes mellitus under normal clinical practice conditions in Macedonia.

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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

Skopje, MK-1000, North Macedonia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • After the physician decision has been made to use biphasic insulin aspart 30 or insulin detemir therapy, any subject with Type 2 diabetes is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before.Particular attention should be paid to the drug interactions that are listed within the product label

Exclusion criteria

  • Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit
  • Subjects currently being treated with biphasic insulin aspart 30 or insulin detemir
  • Subjects who were previously enrolled in this study
  • Subjects with a hypersensitivity to biphasic insulin aspart 30 or insulin detemir or to any of the excipients
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months

Treatment and study plan

insulin detemir

Drug

Safety and effectiveness data collection in connection with the use of the drug.

Other names: NN304, Levemir®

biphasic insulin aspart 30

Drug

Safety and effectiveness data collection in connection with the use of the drug in daily clinical practice.

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs)

    Time frame: after 26 weeks

Secondary outcomes

  1. Number of all minor hypoglycaemic events

    Time frame: during 4 weeks preceding each visit

  2. Number of all major hypoglycaemic events

    Time frame: during 13 weeks preceding each visit

  3. HbA1c

    Time frame: after 26 weeks

  4. Percentage of subjects to reach HbA1c below 7.0%

    Time frame: after 13 weeks and 26 weeks

  5. The effect on glycaemic control as measured by FPG (fasting plasma glucose)

    Time frame: after 13 weeks and 26 weeks

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

    Time frame: after 13 weeks and 26 weeks

  7. Change in body weight

    Time frame: after 13 weeks and 26 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Prospective, Multicentre, Open Label, Non-controlled, Observational, 26-week Study in Patients Using NovoMix® 30 (Biphasic Insulin Aspart 30) or Levemir® (Insulin Detemir) for Treatment of Type 2 Diabetes Mellitus in Macedonia

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 12, 2009
Registry last updated
Aug 15, 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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