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OpenTrials
Completed

NCT Number: NCT00655200

Observational Study of Safety and Tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the Treatment of Type 1 and Type 2 Diabetes Mellitus

This study is conducted in Asia. The aim of this observational study is to evaluate the safety and tolerability of Levemir™ FlexPen™ (Insulin Detemir) in the treatment of Filipino patients with Type 1 and Type 2 Diabetes Mellitus.

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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

0 year–6 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Manila, 1605, Philippines

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed with Type 1 or Type 2 Diabetes Mellitus.
  • Newly diagnosed insulin naive patients
  • Patients currently on human insulin or on basal insulin
  • Patients prescribed with Levemir™ FlexPen™ (Insulin Detemir) therapy
  • Usage should be in accordance with the current prescribing information (See attached prescribing information)

Exclusion criteria

  • Previous history of hypersensitivity to Insulin Detemir (Levemir™) and its excipients (See attached prescribing information)
  • Contraindications and warnings specified in the current prescribing information (See attached prescribing information)
  • Pregnant women, those planning to become pregnant, or women who are breastfeeding
  • Patients who are already on human premix or premix analogue (unless they are going to be shifted to basal-bolus therapy)
  • Children below 6 years old

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. Safety profile of Insulin Detemir among Filipino patients

    Time frame: 3 months follow-up visit

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Apr 9, 2008
Registry last updated
Nov 22, 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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