A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden

N/ACompletedNCT02077946

Novo Nordisk A/S1,059 enrolled

Overview

This trial is conducted in Europe. The aim of this study is to investigate a retrospective database assessment of clinical effectiveness in type 2 diabetes patients treated with liraglutide from primary care centers in Sweden.

Study Type

OBSERVATIONAL

Enrollment

1,059

Conditions

Diabetes Diabetes Mellitus, Type 2

Interventions

liraglutideDRUG

No treatment given.

sitagliptinDRUG

No treatment given.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients from EMR (electronic medical record) system in the primary care in Sweden * Patients equal to or more than 18 years of age * Starting treatment with liraglutide or sitagliptin from January 2010 to December 2013 * Minimum of 180 days of prior follow-up/history within the database before their index date Exclusion Criteria: * Patients with cancer, end stage liver disease, end stage renal failure (non-diabetes related) * Female patients with gestational diabetes during pregnancy * Patients with previous GLP-1 (glucagon-like peptide-1) or DPP-IV (dipeptidyl peptidase-4 ) inhibitor use, i.e. patients should be incretin naïve

Locations (1)

Novo Nordisk Investigational Site

Malmö, Sweden

Outcomes

Primary Outcomes

Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction

Time frame: Day 0, Day 180

Secondary Outcomes

Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only)

Time frame: Day 0, Day 180

HbA1c (NGSP standard, in %) change

Time frame: Day 0, Day 180

Change in weight (in kilograms)

Time frame: Day 0, Day 180

Change in blood pressure (systolic, in mmHg)

Time frame: From baseline to 180 days of therapy

Change in lipids (HDL, LDL and triglycerides, in mmol/L)

Time frame: Day 0, Day 180

Change in creatinine

Time frame: Day 0, Day 180

Data from ClinicalTrials.gov

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