Clinical trial NCT01121315: A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care
Official title: A Retrospective Epidemiological Study to Investigate Outcome and Mortality With Glucose Lowering Drug Treatment in Primary Care
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Type II
Keywords: Epidemiological
Diabetes
Glucose Lowering Drug Treatment in Primary care
CVD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-12
Enrollment: 58326
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible subjects are all type II diabetes patients, found in medical records at the participating centres. Patient data from the period 1 January 1999 - 31 December 2009 will be included in the observation. To ensure a representative selection of primary care centers, selection of study sites will be based on the following criteria to ensure a representative sample of the Swedish population: a mix of rural and urban areas, public and private care providers, small, mid sized and large primary care centers.

Brief summary: To describe the type II diabetes population in primary care with special reference to treatment, other diseases and mortality during the last decade. To test the hypothesis that the type or combination of per oral glucose lowering drugs have different effects on the risk of cardiovascular disease and diabetic complications.


Eligibility criteria: Inclusion Criteria:

* Patients with type II diabetes, according to medical records, diagnosis, prescription or lab assessments

Exclusion Criteria:

* Patients followed by physician for less than 6 months after diagnosis of Diabetes type II

Primary outcomes:
measure: Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality
timeFrame: The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.
Secondary outcomes:
measure: Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications
timeFrame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
measure: Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS)
timeFrame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
measure: Number of consultations in primary care. Number of hospitalisations
timeFrame: The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca Nordic, Södertälje
name: Leif Lohm, MD
role: STUDY_DIRECTOR
affiliation: Uppsala University, Sweden
name: Gunnar Johansson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ödeshögs VC
name: Carl Johan Östgren, MD
role: STUDY_CHAIR
affiliation: Uppsala University Hospital
name: Johan Sundström, MD PhD
role: STUDY_CHAIR
References:
citation: Grundvold I, Bodegard J, Nilsson PM, Svennblad B, Johansson G, Ostgren CJ, Sundstrom J. Body weight and risk of atrial fibrillation in 7,169 patients with newly diagnosed type 2 diabetes; an observational study. Cardiovasc Diabetol. 2015 Jan 15;14:5. doi: 10.1186/s12933-014-0170-3.
citation: Sundstrom J, Sheikhi R, Ostgren CJ, Svennblad B, Bodegard J, Nilsson PM, Johansson G. Blood pressure levels and risk of cardiovascular events and mortality in type-2 diabetes: cohort study of 34 009 primary care patients. J Hypertens. 2013 Aug;31(8):1603-10. doi: 10.1097/HJH.0b013e32836123aa.
citation: Ostgren CJ, Sundstrom J, Svennblad B, Lohm L, Nilsson PM, Johansson G. Associations of HbA1c and educational level with risk of cardiovascular events in 32,871 drug-treated patients with Type 2 diabetes: a cohort study in primary care. Diabet Med. 2013 May;30(5):e170-7. doi: 10.1111/dme.12145. Epub 2013 Mar 13.