Clinical trial NCT02077946: A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden
Official title: A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2014-03-04
Enrollment: 1059
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be analyzed for patients with type 2 diabetes treated with liraglutide or sitagliptin from January 2010 to December 2013, with a treatment length of 180 days.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction
timeFrame: Day 0, Day 180
Secondary outcomes:
measure: Percent (%) of patients with HbA1c (glycosylated haemoglobin) reduction at least 1 %-point and weight reduction at least 3% (NICE clinical guidelines, liraglutide only)
timeFrame: Day 0, Day 180
measure: HbA1c (NGSP standard, in %) change
timeFrame: Day 0, Day 180
measure: Change in weight (in kilograms)
timeFrame: Day 0, Day 180
measure: Change in blood pressure (systolic, in mmHg)
timeFrame: From baseline to 180 days of therapy
measure: Change in lipids (HDL, LDL and triglycerides, in mmol/L)
timeFrame: Day 0, Day 180
measure: Change in creatinine
timeFrame: Day 0, Day 180
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Lind M, Matsson PO, Linder R, Svenningsson I, Jorgensen L, Ploug UJ, Gydesen H, Dorkhan M, Larsen S, Johansson G. Clinical Effectiveness of Liraglutide vs Sitagliptin on Glycemic Control and Body Weight in Patients with Type 2 Diabetes: A Retrospective Assessment in Sweden. Diabetes Ther. 2016 Jun;7(2):321-33. doi: 10.1007/s13300-016-0173-z. Epub 2016 May 23.