NCT02077946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,059

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2014

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 4, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2014

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

7 months

First QC Date

February 28, 2014

Last Update Submit

May 29, 2017

Conditions

DiabetesDiabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

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

    Day 0, Day 180

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (1)

Liraglutide / Sitagliptin

Drug: liraglutideDrug: sitagliptin

Interventions

liraglutideDRUG

No treatment given.

Liraglutide / Sitagliptin
sitagliptinDRUG

No treatment given.

Liraglutide / Sitagliptin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Malmo, 202 15, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 27216947BACKGROUND

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

LiraglutideSitagliptin Phosphate

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2014

First Posted

March 4, 2014

Study Start

February 10, 2014

Primary Completion

September 3, 2014

Study Completion

September 3, 2014

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

SE(1)