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Kumamoto trial: study design

Kumamoto trial: study design. Patients with type 2 diabetes (n = 110). Primary prevention (n = 55). Secondary intervention (n = 55). Randomise. Randomise. Conventional insulin treatment (n = 27). Intensive insulin treatment (n = 28). Conventional insulin treatment (n = 28).

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Kumamoto trial: study design

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  1. Kumamoto trial: study design Patients with type 2 diabetes (n = 110) Primary prevention (n = 55) Secondary intervention (n = 55) Randomise Randomise Conventional insulin treatment (n = 27) Intensive insulin treatment (n = 28) Conventional insulin treatment (n = 28) Intensive insulin treatment (n = 27) Kumamoto trial: Diabetes Care 2000;23(suppl 2):B21–29

  2. Kumamoto trial: treatment conditions Conventional group • Aim: • no symptoms of hyper- or hypoglycaemia • FBG <140 mg/dL • 1 or 2 daily injections of intermediate-acting insulin Intensive group • Aim: • FBG close to <140 mg/dL • 2 hr PPG <200 mg/dL • HbA1c <7.0% • 1 bedtime injection of intermediate-acting insulin + meal-time short-acting insulin • Frequent self-monitoring • Clinic visits every 2 weeks Kumamoto trial: Diabetes Care 2000;23(suppl 2):B21–29

  3. Kumamoto trial: participant characteristics Kumamoto trial: Diabetes Care 2000;23(suppl 2):B21–29

  4. 12 Intensive Conventional 10 8 6 0 0 1 2 3 4 5 6 7 8 Year of study Kumamoto trial: intensive therapy reduced HbA1c HbA1c (%) Adapted from: Diabetes Care 2000;23(suppl 2):B21–29

  5. Intensive Conventional 60 50 50 40 40 30 30 20 20 10 10 0 0 0 1 2 3 4 5 6 7 8 0 1 2 3 4 5 6 7 8 Kumamoto trial: intensive therapy reduced microvascular complications Retinopathy: 68% risk reduction Nephropathy: 74% risk reduction Patients (%) Year of study Adapted from: Diabetes Care 2000;23(suppl 2):B21–29

  6. 40 35 30 25 20 15 10 5 0 Intensive Conventional Kumamoto trial: intensive therapy did not increase severe hypoglycaemia • No incidences of severe hypoglycaemia in either group • Mild hypoglycaemic events occurred only 1.6 times more often with intensive than with conventional treatment Mild hypoglycaemic events per 100 patient years Kumamoto trial: Diabetes Care 2000;23(suppl 2):B21–29

  7. Intensive 22 Conventional 21 20 19 0 Baseline Trial end Kumamoto trial: similar weight gain in both treatment groups BMI (kg/m2) Kumamoto trial: Diabetes Care 2000;23(suppl 2):B21–29

  8. Economic analysis - Kumamoto • “Our results show that multiple injection therapy (MIT) is more beneficial than conventional insulin injection therapy in both cost and effectiveness. MIT is recommended for the treatment of type 2 diabetic patients who require insulin therapy as early as possible from the perspective of both patients and health policy.” Wake N et al. Diab Res Clin Pract 2000;48:201–10

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