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Completed

NCT Number: NCT00709475

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

This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries

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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

6 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Riyadh, 3542, Saudi Arabia

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 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. 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 or studies related to NovoMix 30;
  • Subjects with a hypersensitivity to insulin detemir or to any of the excipients;
  • Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.

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®, NN304

Primary outcomes

  1. Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events

    Time frame: For the duration of the study (32 weeks)

Secondary outcomes

  1. Number of serious adverse events

    Time frame: For the duration of the study

  2. Number of all adverse events

    Time frame: For the duration of the study

  3. Number of all - daytime and nocturnal - hypoglycaemic events

    Time frame: In the 4 weeks before baseline compared to 4 weeks before interim and final visits

  4. Weight changes compared to baseline

    Time frame: At the end of the study

  5. HbA1c compared to baseline

    Time frame: At the end of the study

  6. Fasting glucose level control compared to baseline as measured by FBG

    Time frame: After 16 and 32 weeks of treatment

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Acronym: LevSafeQD

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 3, 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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