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

Completed

• Conditions: Diabetes Mellitus, Type 2; Diabetes
• Interventions: Drug: liraglutide; Drug: sitagliptin

• Registration Number: NCT02077946
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-10
• Study First Submitted: 2014-02-28
• Study First Submitted QC: 2014-02-28
• Study First Posted: 2014-03-04
• Primary Completion: 2014-09-03
• Study Completion: 2014-09-03
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-29
• Last Update Posted: 2017-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1059

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Liraglutide / Sitagliptin	liraglutide	-
Liraglutide / Sitagliptin	sitagliptin	-

Primary Outcome Measures

Name	Time	Method
Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction	Day 0, Day 180

Secondary Outcome Measures

Name	Time	Method
Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only)	Day 0, Day 180
HbA1c (NGSP standard, in %) change	Day 0, Day 180
Change in weight (in kilograms)	Day 0, Day 180
Change in blood pressure (systolic, in mmHg)	From baseline to 180 days of therapy
Change in lipids (HDL, LDL and triglycerides, in mmol/L)	Day 0, Day 180
Change in creatinine	Day 0, Day 180

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇸🇪 Malmö, Sweden