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Objective: We sought to ascertain quality-of-life measures and utility values associated with visual acuity in type 2 diabetes., Research Design and Methods: The Medical Outcome Study Short Form with 36 items (SF-36) was administered to 4,051 individuals with type 2 diabetes who were enrolled in the Lipids in Diabetes Study, and their best attainable vision was determined using an Early Treatment of Diabetic Retinopathy Study chart, expressed as a LogMAR score. Eight domain scores and a utility value representing an overall quality-of-life score were calculated using predefined algorithms. The associations between quality of life measured and best-eye visual acuity were assessed graphically and by regression analysis., Results: All eight SF-36 domain scores were negatively associated with reduced visual acuity. The impact of lower levels of visual acuity ranged from a decline of 1.3 units for a 0.1-LogMAR increase for physical functioning and 0.6 units in mental health. Regression analysis indicated a negative association (P < 0.001) between utility and reduced visual acuity after controlling for sex, BMI, smoking status, and history of diabetes complications. Patients whose LogMAR scores equated to legally blind had, on average, 0.054 (95% CI 0.034-0.074) lower utility compared with patients with normal visual acuity., Conclusions: Reduced visual acuity is negatively associated with quality of life. The utility scores estimated here should inform studies quantifying the burden of diabetes and those evaluating potential therapies for treating or preventing diabetic eye diseases.

Objective: Type 2 diabetes may be present for several years before diagnosis, by which time many patients have already developed diabetic complications. Earlier detection and treatment may reduce this burden, but evidence to support this approach is lacking., Research Design and Methods: Glycemic control and clinical and surrogate outcomes were compared for 5,088 of 5,102 U.K. Diabetes Prospective Study participants according to whether they had low (<140 mg/dl [<7.8 mmol/l]), intermediate (140 to <180 mg/dl [7.8 to <10.0 mmol/l]), or high (> or =180 mg/dl [> or =10 mmol/l]) fasting plasma glucose (FPG) levels at diagnosis. Individuals who presented with and without diabetic symptoms were also compared., Results: Fewer people with FPG in the lowest category had retinopathy, abnormal biothesiometer measurements, or reported erectile dysfunction. The rate of increase in FPG and HbA(1c) during the study was identical in all three groups, although absolute differences persisted. Individuals in the low FPG group had a significantly reduced risk for each predefined clinical outcome except stroke, whereas those in the intermediate group had significantly reduced risk for each outcome except stroke and myocardial infarction. The low and intermediate FPG groups had a significantly reduced risk for progression of retinopathy, reduction in vibration sensory threshold, or development of microalbuminuria., Conclusions: People presenting with type 2 diabetes with lower initial glycemia who may be earlier in the course of their disease had fewer adverse clinical outcomes despite similar glycemic progression. Since most such people are asymptomatic at diagnosis, active case detection programs would be required to identify them.

Objective: To evaluate the efficacy of the addition of insulin when maximal sulfonylurea therapy is inadequate in individuals with type 2 diabetes., Research Design and Methods: Glycemic control, hypoglycemia, and body weight were monitored over 6 years in 826 patients with newly diagnosed type 2 diabetes in 8 of 23 U.K. Prospective Diabetes Study (UKPDS) centers that used a modified protocol. Patients were randomly allocated to a conventional glucose control policy, primarily with diet (n = 242) or an intensive policy with insulin alone (n = 245), as in the main study. However, for patients randomized to an intensive policy with sulfonylurea (n = 339), insulin was added automatically if the fasting plasma glucose remained >108 mg/dl (6.0 mmol/l) despite maximal sulfonylurea doses., Results: Over 6 years, approximately 53% of patients allocated to treatment with sulfonylurea required additional insulin therapy. Median HbA(1c) in the sulfonylurea +/- insulin group was significantly lower (6.6%, interquartile range [IQR] 6.0-7.6) than in the group taking insulin alone (7.1%, IQR 6.2-8.0; P = 0.0066), and significantly more patients in the sulfonylurea +/- insulin group had an HbA(1c) <7% (47 vs. 35%, respectively; P = 0.011). Weight gain was similar in the intensive therapy groups, but major hypoglycemia occurred less frequently over all in the sulfonylurea (+/- insulin) group compared with the insulin alone group (1.6 vs. 3.2% per annum, respectively; P = 0.017)., Conclusions: Early addition of insulin when maximal sulfonylurea therapy is inadequate can significantly improve glycemic control without promoting increased hypoglycemia or weight gain.

Objective: To assess the relationship among self-reported ethnicity, metabolic control, and blood pressure during treatment of type 2 diabetes., Research Design and Methods: We studied 2,999 newly diagnosed type 2 diabetic patients recruited to the U.K. Prospective Diabetes Study who were randomized to conventional or intensive glucose control policies if their fasting plasma glucose levels remained >6 mmol/l after a dietary run-in. A total of 2,484 patients (83%) were white Caucasian (WC), 265 patients (9%) were Afro-Caribbean (AC), and 250 patients (8%) were Asian of Indian origin (IA). Variables were assessed at 3, 6, and 9 years., Results: During the 9-year study period, body weight increased more in WC patients (mean 5.0 kg) than in AC (3.0 kg) and IA (2.5 kg) patients (P < 0.001). After adjusting for age, sex, baseline value, treatment allocation, and change in weight, there were no consistent ethnic differences in mean change in fasting plasma glucose or HbA(1c). After adjustment for antihypertensive therapy, increase in systolic blood pressure at 9 years was greatest in AC patients (7 mmHg; P < 0.01 vs. WC patients). Mean diastolic blood pressure, total cholesterol, and LDL cholesterol decreased progressively during the 9 years in each group. In AC patients, the mean increase in HDL cholesterol (0.16 mmol/l) at 3 years, maintained to 9 years, and the mean decrease in plasma triglyceride level (0.4 mmol/l) at 9 years were greater than in WC and IA patients (P < 0.001)., Conclusions: This study shows important ethnic differences in body weight, lipid profiles, and blood pressure, but not glycemic control, during 9 years after diagnosis of type 2 diabetes. AC patients maintained the most favorable lipid profiles, but hypertension developed in more AC patients than WC or IA patients. Ethnicity-specific glycemic control of type 2 diabetes seems unnecessary, but other risk factors need to be addressed independently.

Objective: To determine the degree to which alpha-glucosidase inhibitors, with their unique mode of action primarily reducing postprandial hyperglycemia, offer an additional therapeutic approach in the long-term treatment of type 2 diabetes., Research Design and Methods: We studied 1,946 patients (63% men) who were previously enrolled in the U.K. Prospective Diabetes Study (UKPDS). The patients were randomized to acarbose (n = 973), titrating to a maximum dose of 100 mg three times per day, or to matching placebo (n = 973). Mean +/- SD age was 59 +/- 9 years, body weight 84 +/- 17 kg, diabetes duration 7.6 +/- 2.9 years, median (interquartile range) HbA1c 7.9% (6.7-9.5), and fasting plasma glucose (FPG) 8.7 mmol/l (6.8-11.1). Fourteen percent of patients were treated with diet alone, 52% with monotherapy, and 34% with combined therapy. Patients were monitored in UKPDS clinics every 4 months for 3 years. The main outcome measures were HbA1c, FPG, body weight, compliance with study medication, incidence of side effects, and frequency of major clinical events., Results: At 3 years, a lower proportion of patients were taking acarbose compared with placebo (39 vs. 58%, P < 0.0001), the main reasons for noncompliance being flatulence (30 vs. 12%, P < 0.0001) and diarrhea (16 vs. 8%, P < 0.05). Analysis by intention to treat showed that patients allocated to acarbose, compared with placebo, had 0.2% significantly lower median HbA1c at 3 years (P < 0.001). In patients remaining on their allocated therapy, the HbA1c difference at 3 years (309 acarbose, 470 placebo) was 0.5% lower median HbA1c (8.1 vs. 8.6%, P < 0.0001). Acarbose appeared to be equally efficacious when given in addition to diet alone; in addition to monotherapy with a sulfonylurea, metformin, or insulin; or in combination with more complex treatment regimens. No significant differences were seen in FPG, body weight, incidence of hypoglycemia, or frequency of major clinical events., Conclusions: Acarbose significantly improved glycemic control over 3 years in patients with established type 2 diabetes, irrespective of concomitant therapy for diabetes. Careful titration of acarbose is needed in view of the increased noncompliance rate seen secondary to the known side effects.