UKPDS 33

Is intensive policy with a sulphonylurea (chlorpropamide, glibenclamide, or glipizide) or with insulin superior to conventional policy with diet?

Study design

Population

3867 patients (1508 female, 2359 male)
Inclusion criteria: patients with T2DM, median age 54 years, who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of

6.1-15.0 mmol/L

• Key exclusion criteria: ketonuria > 3 mmol/L; serum creatinine > 175 Mmol/L; myocardial infarction in the previous year; current angina or HF; > 1 major vascular event; retinopathy requiring laser treatment; malignant

HT; or uncorrected endocrine disorder

Interventions

N=2729 intensive blood-glucose treatment (with sulphonylurea, chlorpropamide, glibenclamide, or glipizide; or insulin, target FPG < 6 mmol/L)
N=1138 conventional treatment (aim to best achieve
FPG with diet alone)

Primary outcome

Incidence of diabetes-related events

Significant decrease in the incidence of diabetes-related events (40.9 /1000 py vs. 46 /1000 py; RR 0.88, 95% CI 0.79 to 0.99)

Secondary outcomes

No significant difference in the incidence of diabetes-related death (10.4 /1000 py vs. 11.5 /1000 py; RR 0.9, 95% Cl 0.73 to 1.11)
No significant difference in the incidence of death from any cause (17.9 /1000 py vs. 18.9 /1000 py; RR 0.94, 95% CI 0.8 to 1.1)

Safety outcomes

Significant differences in hypoglycemic episodes (p <0.0001) and weight gain (mean 2.9 kg, p < 0.001).

Conclusion

In patients with T2DM, median age 54 years, who after 3 months' diet treatment had a mean of two fasting plasma glucose (FPG) concentrations of 6.1-15.0 mmol/L, intensive blood-glucose treatment was superior to conventional treatment with respect to the incidence of diabetes-related events.