Table 1.
Study | Study design | Key findings |
---|---|---|
4-T24 | • n = 708 T2D patients suboptimally controlled on maximally tolerated doses of metformin and SU for at least 4 months • Add-on bipnasic, prandial, or basal insulin • Target: HbA1c £8.5% |
• Better glycemic control with add-on basal or prandial insulin (43.2% and 44.7% reached target, respectively) compared with biphasic insulin (31.9%) |
ACCORD17 | • N = 10 251 patients with T2D and either additional CV risk factors or established CVD • Intensive therapy vs standard therapy • Target HbAlc *6.0% (intensive therapy): HbA1o 7.0-7.9% (standard therapy) |
• Intensive therapy associated with increased annual rate of hypoglycemia requiring medical assistance compared with standard therapy (3.1% vs 1.0%. P < .001) |
DCCT25 and EDIC27 | • N = 1441 patients with T1D • Intensive therapy vs conventional therapy • Intensive target preprandial BG 7D-120 mgydl. PPG < 180 mg/dl. weekly lam > 65 mg/dl and monthly HbAlc < 6.05% |
• Intensive therapy delays onset and progression of nephropathy, neuropathy, and retinopathy by 35-90% compared with standard therapy • Risk reductions for various diabetic complications were maintained for 7 years |
HEART2D22 | • N = 1115 T2D patients with recent acute myocardial infarction • Prandial vs basal strategy • Target HbA1c < 7.0% |
• No significant difference in risk for future CV event between prandial and basal strategies (31.2% vs 32.4%) • Mean HbA1C not different between prandial and basal strategies (7.7 ± 0.1 vs 7.8±0.1%, P = .4) • Mean daily PPG (7 8 vs 8.6 mmol/l, P < .01) and 2-h PPG excursion (0.1 vs 1.3 mmol/l, P < .001) lower with prandial vs basal strategy • Mean FBG lower in basal vs prandial group (7.0 vs 8.1 mmol/l, P < .001) |
ORGIN2,13 | • N = 12 537 patients with IFG and/or IGT newly detected or early T2D • Insulin glargine vs standard care • Target FPG 95 mg/dl |
• Insulin glargine had a neutral effect on CV outcomes vs standard care (2.94 vs 2.85 per 100 person-years, P = .63) • 3-fold increase in likelihood of achieving and maintaining HbAlc < 6.5% with SMBG use (P < .001) • Rate of severe hypoglycemia 1.00 vs 0.31 per 100 person-years (–0.7 more severe episodes and 11 more suspected/confirmed episodes per 100 person-years) |
TITRATE™23 | • N = 244 insulin-naïve subjects with T2D insufficiently controlled on oral antidiabetic drugs • Two FPG targets: 80-110 mg/dl, 70-90 mg/dl • Target HbAlc *7% |
• 64 3% of patients in 70-90 mg/dl group achieved HbAlc target vs 54.5% in 60-110 mg/dl group (P = .04) • Decreases in HbAlc from baseline favored 70-90 mg/dl group (P = .0019) |
UKPDS16 | • N = 3867 patients with newly diagnosed T2D • Intensive treatment (SU or insulin) vs conventional treatment with diet • Target < 6 mmoUI (intensive group), best achievable FPG with diet alone (conventional group) |
• Rate of major hypoglycemic episodes pet year 0.7% with conventional treatment, 1.0% with chlorpropamide, 1.4% with ghbenclamide, and 1.8% with insulin |
VADT18,31 | • N = 1791 military veterans with suboptimal response to therapy for T2D • Intensive therapy vs standard therapy • Target HbAlc < 6.0% (intensive therapy), HbAlc < 9.0% (standard therapy) |
• Intensive therapy associated with increased annual rate of severe hypoglycemia compared with standard therapy (3.8% vs 1.8%) |
Abbreviations: BG, blood glucose; CV, cardiovascular; CVD, cardiovascular disease; FBG, fasting blood glucose; FPG, fasting plasma glucose; HbA1c, hemoglobin A1c; PPG, postprandial glucose; SMBG, self-monitoring of blood glucose; SU, sulfonylurea; T1D, type 1 diabetes; T2D, type 2 diabetes.