Efficacy of intensive multitherapy for patients with type 2 diabetes mellitus:: a randomized controlled trial

Background: National guidelines for managing diabetes set standards for care. We sought to determine whether a 1-year intensive multitherapy program resulted in greater goal attainment than usual care among patients with poorly controlled type 2 diabetes mellitus. Methods: We identified patients with poorly controlled type 2 diabetes receiving outpatient care in the community or at our hospital. Patients 30 - 70 years of age with a hemoglobin A(1C) concentration of 8% or greater were randomly assigned to receive intensive multitherapy (n = 36) or usual care (n = 36). Results: The average hemoglobin A(1C) concentration at entry was 9.1% (standard deviation [SD] 1%) in the intensive therapy group and 9.3% (SD 1%) in the usual therapy group. By 12 months, a higher proportion of patients in the intensive therapy group than in the control group had achieved Canadian Diabetes Association (CDA) goals for hemoglobin A(1C) concentrations (goal <= 7.0%: 35% v. 8%), diastolic blood pressure ( goal < 80 mm Hg: 64% v. 37%), low-density lipoprotein cholesterol (LDL-C) levels ( goal < 2.5 mmol/L: 53% v. 20%) and triglyceride levels ( goal < 1.5 mmol/L: 44% v. 14%). There were no significant differences between the 2 groups in attaining the targets for fasting plasma glucose levels, systolic blood pressure or total cholesterol: high-density lipoprotein cholesterol ratio. None of the patients reached all CDA treatment goals. By 18 months, differences in goal attainment were no longer evident between the 2 groups, except for LDL-C levels. Quality of life, as measured by a specific questionnaire, increased in both groups, with a greater increase in the intensive therapy group (13% [SD 10%] v. 6% [SD 13%], p < 0.003). Interpretation: Intensive multitherapy for patients with poorly controlled type 2 diabetes is successful in helping patients meet most of the goals set by a national diabetes association. However, 6 months after intensive therapy stopped and patients returned to usual care, the benefits had vanished.