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NCT Number: NCT00738153

An Observational Study on Efficacy and Safety in Subjects Using Levemir® for the Treatment of Insulin Dependent Type 1 or Type 2 Diabetes

This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin 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

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Casablanca, 20000, Morocco

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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
  • Currently being treated with insulin detemir
  • Previously enrolled in this study
  • 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.

Treatment and study plan

insulin detemir

Drug

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

Other names: Levemir®

Primary outcomes

  1. The incidence of serious adverse drug reactions, including major hypoglycaemic events

    Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively

Secondary outcomes

  1. Number of serious adverse events

    Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively

  2. Number of all adverse events

    Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively

  3. Number of all hypoglycaemic events

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

  4. Weight changes

    Time frame: at the end of study

  5. HbA1c

    Time frame: at the end of study

  6. Sub -group analysis of hypo risk

    Time frame: From baseline to 12 and 24 weeks of Levemir® therapy, respectively

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Efficacy and Safety Study of Levemir® (Insulin Detemir) to Treat Type 1 and 2 Diabetes Mellitus

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Aug 20, 2008
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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