Evaluating the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes

Novo Nordisk A/S4,121 enrolled

Overview

This trial is conducted in Asia. The aim of the trial is to assess the incidence rate and type of SADRs (serious adverse drug reactions).

Study Type

OBSERVATIONAL

Enrollment

4,121

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects, who require treatment with liraglutide Exclusion Criteria: * Subjects who are or have previously been on liraglutide * Subjects who have previously been enrolled in the study * Subjects with a hypersensitivity to liraglutide or to any of the excipients * Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the study periods * Subjects with cancer (except basal cell skin cancer or squamous cell skin cancer) or any clinically significant disorder, except for conditions associated with type 2 diabetes mellitus history which in the physicians' opinion could interfere with the results of the trial * Known or suspected abuse of alcohol or narcotics

Locations (1)

Novo Nordisk Investigational Site

Tokyo, Japan

Outcomes

Primary Outcomes

The incidence of SADRs (Serious Adverse Drug Reactions)

Time frame: After 36 months

Secondary Outcomes

The incidence rate and type of SAEs (Serious Adverse Events)

Time frame: At month 1, 3, 6, 12, 24 and 36

The incidence rate and type of ADRs (Adverse Drug Reactions)

Time frame: At month 1, 3, 6, 12, 24 and 36

Data from ClinicalTrials.gov

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