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Completed

NCT Number: NCT00701155

Observational Study to Evaluate the Safety While Using Levemir®

This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.

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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

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Giza, 0020, Egypt

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 insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.

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 insulin detemir;
  • Subjects who previously enrolled in this study
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients
  • Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)

Treatment and study plan

insulin detemir

Drug

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

Other names: Levemir®

Primary outcomes

  1. Incidence of serious ADRs incl. major hypoglycemias

    Time frame: after 24 weeks

Secondary outcomes

  1. Number of serious adverse events

    Time frame: after 24 weeks

  2. Number of all adverse events

    Time frame: after 24 weeks

  3. Weight changes

    Time frame: after 24 weeks

  4. HbA1c

    Time frame: after 24 weeks

  5. Subgroup analysis of hypoglycemias

    Time frame: after 24 weeks

  6. Number of all hypoglycemic events

    Time frame: in the 4 weeks preceding the visits at 12 weeks and 24 weeks.

  7. Variability in fasting Blood Sugar and average plasma glucose levels

    Time frame: after 24 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Observational, Safety Study in Subjects Using Insulin Detemir for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes Mellitus

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 19, 2008
Registry last updated
Nov 2, 2023

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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