Observational Study to Evaluate Safety of Levemir® in Type 1 and Type 2 Diabetes

Novo Nordisk A/S1,531 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

1,531

Conditions

Diabetes Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2

Interventions

insulin detemirDRUG

For study drug, start dose and frequency of administration to be prescribed by the physician as a result of normal clinical evaluation

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 or type 2 diabetes mellitus Exclusion Criteria: * Subjects who are unlikely to comply with the protocol * Subjects who are currently being treated with Levemir® * Subjects who previously were enrolled into the study * Subjects with hypersensitivity to Levemir® or any of its excipients

Locations (1)

Novo Nordisk Investigational Site

Jakarta, Indonesia

Outcomes

Primary Outcomes

Incidence of serious adverse drug reactions (SADRs)

Time frame: during treatment

Major hypoglycaemic events

Time frame: during treatment

Secondary Outcomes

Number of serious adverse events

Time frame: during treatment

Number of all adverse events

Time frame: during treatment

Number of all hypoglycaemic events

Time frame: the last 4 weeks of treatment

Weight changes

Time frame: after 12 weeks

HbA1c

Time frame: after 12 weeks and 26 weeks of treatment

Variability in fasting blood glucose (FBG) and average plasma glucose level

Time frame: after 12 weeks

Data from ClinicalTrials.gov

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