Diabetes Mellitus, Type 2 Clinical Trial
Official title:
A Retrospective Database Assessment of Clinical Effectiveness in Type 2 Diabetes Patients Treated With Liraglutide From Primary Care Centers in Sweden
| Verified date | May 2017 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 1059 |
| Est. completion date | September 3, 2014 |
| Est. primary completion date | September 3, 2014 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Novo Nordisk Investigational Site | Malmö |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Sweden,
Lind M, Matsson PO, Linder R, Svenningsson I, Jørgensen 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percent (%) of patients achieving at least 1 %-point HbA1c (glycosylated haemoglobin) reduction | Day 0, Day 180 | ||
| Secondary | 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 | ||
| Secondary | HbA1c (NGSP standard, in %) change | Day 0, Day 180 | ||
| Secondary | Change in weight (in kilograms) | Day 0, Day 180 | ||
| Secondary | Change in blood pressure (systolic, in mmHg) | From baseline to 180 days of therapy | ||
| Secondary | Change in lipids (HDL, LDL and triglycerides, in mmol/L) | Day 0, Day 180 | ||
| Secondary | Change in creatinine | Day 0, Day 180 |
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