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. 2017 Jun 8;2017(6):CD010137. doi: 10.1002/14651858.CD010137.pub2

ACCORD Study 2007.

Methods

  • Study design: parallel RCT

  • Duration of study (recruitment): January 2001 through early June 2001 during a “vanguard” phase, and January 2003 through October 2005

  • Follow‐up period: 42 months
Participants

  • Country: USA and Canada

  • Setting: multicentre (77)

  • Patients with stage 1 CKD with type 2 diabetes, HbA1c concentrations of ≥ 7.5%; aged 40 to 79 years with history of cardiovascular disease or 55 to 79 years with anatomical evidence of significant atherosclerosis, albuminuria, left ventricular hypertrophy;; at least two risk factors for cardiovascular disease (dyslipidaemia, hypertension, being a smoker, or obesity)

  • Number: treatment group (5128); control group (5123)

  • Mean age ± SD (years): treatment group (62.2 ± 6.8); control group (62.2 ± 6.8)

  • Sex (M/F): treatment group (3143/1985); control group (3156/1967)

  • Exclusion criteria: frequent or recent serious hypoglycaemic events; unwillingness to monitor glucose at home or inject insulin; BMI > 45 kg/m2; SCr > 132.6 μmol/L; other serious illness
Interventions Treatment group

  • Intensive treatment targeting a HbA1c concentration of < 6.0%


Control group

  • Standard treatment targeting HbA1c of 7.0% to 7.9%
Outcomes

  • First occurrence of nonfatal myocardial infarction or nonfatal stroke or death from cardiovascular causes

  • Death from any cause was one of several prespecified secondary outcomes
Notes

  • Funding source: Abbott Laboratories, Amylin Pharmaceutical, AstraZeneca Pharmaceuticals LP, Bayer HealthCare LLC, Closer Healthcare, GlaxoSmithKline Pharmaceuticals, King Pharmaceuticals, Merck, Novartis Pharmaceuticals, Novo Nordisk, Omron Healthcare, Sanofi‐Aventis US, and Takeda Pharmaceuticals
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomisation sequences were computer generated for every clinical site centrally at the coordinating centre
Allocation concealment (selection bias) Unclear risk Randomisation was stratified by clinical site with permuted blocks. Methods to assure allocation concealment were not reported.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Data on clinical outcomes were adjudicated by a central committee whose members were unaware of study group assignments
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 50/10251 lost to follow‐up (0.5%)
Selective reporting (reporting bias) Low risk Important patient‐level outcomes provided
Other bias High risk Data not independent of sponsor