A Retrospective Study of Cardiovascular Events Related to the Use of Glucose Lowering Drug Treatment in Primary Care

NCT01121315 | Completed

• 1 other identifier: NIS-CSE-DUM-2010/1
• Study Type: observational
• Target: 58,326
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Type II

Keywords

Epidemiological; Diabetes; Glucose Lowering Drug Treatment in Primary care; CVD

Outcome Measures

Primary Outcomes (1)

• Composite end-point consisting of Cardiovascular Disease, elective coronary revascularisation and mortality

  The endpoints will be extracted from the medical records on one occassion, covering a period of one decade.

Secondary Outcomes (3)

• Retinopathy, renal failure, hypoglycaemic episodes, other diabetic complications

  The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.

• Time from: Metformin (MET) to Insulin (INS) versus Metformin (MET) -> Metformin (MET)+Sulfonylurea (SU) ->Insulin (INS)

  The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.

• Number of consultations in primary care. Number of hospitalisations

  The endpoints will be extracted from the medical records on one occasion, covering a period of one decade.

Study Arms (1)

1

Diabetes type II patients, according to medical records, prescriptions or lab results, followed for \>6 months after diagnosis.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Uppsala, Sweden

Location

Related Publications (3)

• 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.

  PMID: 25589001 DERIVED

• 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.

  PMID: 23625112 DERIVED

• 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.

  PMID: 23350893 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Leif Lohm, MD

  AstraZeneca Nordic, Södertälje

  STUDY DIRECTOR

• Gunnar Johansson, MD

  Uppsala University, Sweden

  PRINCIPAL INVESTIGATOR

• Carl Johan Östgren, MD

  Ödeshögs VC

  STUDY CHAIR

• Johan Sundström, MD PhD

  Uppsala University Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

SE (1)