Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/S254 enrolled

Overview

The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.

Study Type

OBSERVATIONAL

Enrollment

254

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Type 2 diabetes * Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs) Exclusion Criteria: * Previously treated with liraglutide * Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections) * Pregnant, breast feeding or have the intention of becoming pregnant

Locations (1)

Novo Nordisk Investigational Site

Brussels, Belgium

Outcomes

Primary Outcomes

Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%

Time frame: month 12

Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%

Time frame: month 12

Secondary Outcomes

HbA1c

Time frame: month 12

Fasting blood glucose (FBG)

Time frame: month 12

Incidence of serious adverse events (SAEs)

Time frame: months 0-12

Incidence of adverse drug reactions (ADRs)

Time frame: months 0-12

Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)

Time frame: months 0-12

Data from ClinicalTrials.gov

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