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Completed

NCT Number: NCT00700765

Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of adverse events while using 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

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Jakarta, 12520, Indonesia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Type 1 or type 2 diabetes mellitus

Exclusion criteria

  • Subjects who are unlikely to comply with the protocol
  • Subjects who are currently being treated with Levemir®
  • Subjects who previously were enrolled into the study
  • Subjects with hypersensitivity to Levemir® or any of its excipients

Treatment and study plan

insulin detemir

Drug

For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation

Other names: Levemir®

Primary outcomes

  1. Incidence of serious adverse drug reactions (SADRs)

    Time frame: during treatment

  2. Major hypoglycaemic events

    Time frame: during treatment

Secondary outcomes

  1. Number of serious adverse events

    Time frame: during treatment

  2. Number of all adverse events

    Time frame: during treatment

  3. Number of all hypoglycaemic events

    Time frame: the last 4 weeks of treatment

  4. Weight changes

    Time frame: after 12 weeks

  5. HbA1c

    Time frame: after 12 weeks and 26 weeks of treatment

  6. Variability in fasting blood glucose (FBG) and average plasma glucose level

    Time frame: after 12 weeks

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jun 19, 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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