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Completed

NCT Number: NCT01542463

Evaluation of the Use of Levemir® in Insufficiently Controlled Patients With Type 1 or Type 2 Diabetes

This study conducted in Europe. The aim of this study is to evaluated the use of insulin detemir (Levemir®) in insufficiently controlled patients with type 1 or type 2 diabetes.

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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

Mainz, 55127, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients with insufficiently controlled type 1 or type 2 diabetes mellitus under their previous therapy

Treatment and study plan

insulin detemir

Drug

Prescribed at the discretion of the physician

Primary outcomes

  1. HbA1c (glycaemic haemoglobin)

  2. Fasting plasma glucose (FBG)

Secondary outcomes

  1. Body weight change

  2. Adverse drug reactions (ADR)

  3. Serious adverse drug reactions (SADR)

  4. Hypoglycaemic episodes

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Levemir®: the Physiological Basal Insulin. Documentation of Safety Aspects, Glycaemic Control and Weight

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Mar 2, 2012
Registry last updated
Mar 3, 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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