title: Determinants of successful glycemic control among participants in the BARI 2D trial: a post-hoc analysis.
abstract: OBJECTIVE
  The BARI 2D trial compared insulin provision (IP) versus insulin sensitization (IS) for the primary outcome of total mortality in participants with T2DM and cardiovascular disease (CVD). In this analysis we examine baseline characteristics that are associated with successful long-term glycemic control.
  
  
  METHODS
  In a 2×2 factorial design, 2368 participants were randomized to either IP or IS therapy, and to either prompt revascularization with medical therapy or medical therapy alone. Successful long-term glycemic control (success) was defined by simultaneously meeting 1) a mean HbA1c level of <7.0% after each participant's third year of follow-up period, and 2) adherence with medications only from the assigned glycemic treatment arm during >80% of the BARI 2D follow-up. The association between baseline variables and success was determined using unadjusted and adjusted logistic regression models.
  
  
  RESULTS
  1917 participants (962 IP and 955 IS participants) had sufficiently long follow-up and data for this analysis. Among these IP and IS participants, 235 and 335 participants met both criteria of success, respectively (p<0.001). Those not on insulin at entry had higher odds of success (OR 2.25; CI 1.79-2.82) when treated with IS versus IP medications, irrespective of baseline HbA1c levels. Younger age, shorter duration of T2DM, and lower HbA1c at baseline were also each independently associated with higher success when treated with IS versus IP medications.
  
  
  CONCLUSIONS
  Patients similar to those in the BARI 2D trial may have a higher chance of achieving success with IS versus IP medications if they are younger, have shorter duration of T2DM, have lower HbA1c levels, have moderate or strenuous physically activity, and are not on insulin. In contrast, increasing age, longer duration of T2DM, higher HbA1c, and insulin therapy are associated with increased chance of success if treated with IP medications.
authors.affiliation: Department of Medicine, Case Western Reserve University and Cleveland VA Medical Center, Cleveland, OH, USA. Electronic address: fxi2@case.edu.
authors.forename: Faramarz
authors.initials: F
authors.lastname: Ismail-Beigi
authors.affiliation: Department of Epidemiology, University of Pittsburgh, Pittsburgh, PA, USA.
authors.forename: Manuel S
authors.initials: MS
authors.lastname: Lombardero
authors.affiliation: Clinical Research Center. Regional Hospital No. 1. Mexican Institute of Social Security. Gabriel Mancera 222, Col. del Valle. 03100 Benito Juarez, DF. Mexico.
authors.forename: Jorge
authors.initials: J
authors.lastname: Escobedo
authors.affiliation: Department of Medicine, Case Western Reserve University, Cleveland, OH, USA.
authors.forename: Saul
authors.initials: S
authors.lastname: Genuth
authors.affiliation: Department of Medicine, Division of Endocrinology, Duke University Medical Center and Durham VA Medical Center, Durham, NC, USA.
authors.forename: Jennifer
authors.initials: J
authors.lastname: Green
authors.affiliation: Northwestern University Feinberg School of Medicine, Chicago, IL, USA.
authors.forename: Elaine
authors.initials: E
authors.lastname: Massaro
authors.affiliation: University of Florida College of Medicine, Jacksonville, FL, USA.
authors.forename: Arshag D
authors.initials: AD
authors.lastname: Mooradian
authors.affiliation: Department of Medicine, University of Alabama at Birmingham School of Medicine and Birmingham VA Medical Center, Birmingham, AL, USA.
authors.forename: Fernando
authors.initials: F
authors.lastname: Ovalle
authors.affiliation: Division of Endocrinology, Diabetes and Bone and Mineral Diseases, Henry Ford Health System, Detroit, MI, USA.
authors.forename: Fred
authors.initials: F
authors.lastname: Whitehouse
authors.affiliation: Albert Einstein College of Medicine, Montefiore Clinical Diabetes Center, Bronx, NY, USA.
authors.forename: Joel
authors.initials: J
authors.lastname: Zonszein
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001786:Blood Glucose / Q000187:drug effects / Q000378:metabolism*; D002986:Clinical Trials as Topic; D003924:Diabetes Mellitus, Type 2 / Q000188:drug therapy* / Q000378:metabolism / Q000401:mortality; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D007328:Insulin / Q000627:therapeutic use*; D007333:Insulin Resistance; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D016896:Treatment Outcome
chemical_list: D001786:Blood Glucose; D007004:Hypoglycemic Agents; D007328:Insulin
keywords: Cardiovascular disease; Plasma insulin levels; Predictors of glycemic control