Observational Study to Evaluate the Safety of Levemir® in Diabetes

This observational study is conducted in North America. The aim of this observational study is to evaluate the incidence of adverse events while using Levemir® under normal clinical practice conditions.

Completed

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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

Mexico City, Mexico

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Type 1 or 2 diabetes
Including newly diagnosed not on insulin or insulin analogue treatment
Selection at the discretion of the physician
Adult patients with type 1 and 2 diabetes mellitus, and type 1 patients 6 years and older

Exclusion criteria

Current treatment with Levemir®
Previously enrolled in the study
Hypersensitivity to Levemir®

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

Incidence of SADR (serious adverse drug reactions ) incl major hypo (hypoglycaemic events)

Time frame: during treatment

Secondary outcomes

Glucose control measures

Time frame: during treatment
Weight

Time frame: during treatment

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

Acronym: PREDICTIVE™

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 27, 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.

Published trials that share one or more normalized conditions with this study.

Completed