Observational Study to Evaluate the Safety of Levemir® in Diabetes (PREDICTIVE™)

Novo Nordisk

Status: Completed

Conditions: Diabetes Mellitus, Type 1; Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: insulin detemir

Study type: Observational

Funder types: Industry

Identifiers

NCT00659295

NN304-1677

Details and patient eligibility

About

This study is conducted in Africa, Asia, Europe, Japan and South America. The aim of this observational study is to evaluate the incidence of serious adverse reactions (SARs) while using Levemir® (insulin detemir) under normal clinical practice conditions.

Study conducted globally in 26 countries. Some countries participated in the study for only 3 months (Austria, Brazil, Denmark, Germany, Israel, Lebanon, Slovenia, Russia, and Turkey), while others extended their participation to 6 (Belgium/Luxembourg, Czech Republic, Greece, India, Italy, Netherlands, Saudi Arabia, South Africa, South Korea, Sweden, Tunisia, and United Kingdom/Ireland) and 12 months (Finland, France, and Japan), respectively.

Enrollment: 51,170 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age according to approved label in each country and physician discretion
• Type 1 or 2 diabetes
• Recently started treatment with insulin detemir at the discretion of the investigator. Before initiation of insulin detemir they should not have been treated with insulin
• Selection at the discretion of the physician

Exclusion criteria

• Current treatment with Levemir® (insulin detemir)
• Previously enrolled in the study
• Hypersensitivity to Levemir® (insulin detemir)

Trial design

51,170 participants in 2 patient groups

Type 1 diabetes

Description:

Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.

Treatment:

Drug: insulin detemir

Type 2 diabetes

Description:

Prescription of insulin detemir (Levemir®) according to local approved labelling by prescribing physician in a normal clinical practice to patients with type 1 diabetes, including newly diagnosed patients who have never received insulin or analogue treatment.

Treatment:

Drug: insulin detemir