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Completed

NCT Number: NCT02077946

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

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site

Malmö, 202 15, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liraglutide

Drug

No treatment given.

Sitagliptin

Drug

No treatment given.

Primary outcomes

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

    Time frame: Day 0, Day 180

Secondary outcomes

  1. 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

  2. HbA1c (NGSP standard, in %) change

    Time frame: Day 0, Day 180

  3. Change in weight (in kilograms)

    Time frame: Day 0, Day 180

  4. Change in blood pressure (systolic, in mmHg)

    Time frame: From baseline to 180 days of therapy

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

    Time frame: Day 0, Day 180

  6. Change in creatinine

    Time frame: Day 0, Day 180

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Mar 4, 2014
Registry last updated
May 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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