ABSTRACT
AIMS: To compare the effect of adding nateglinide or placebo on postprandial glucose excursions (PPGEs), glycated haemoglobin (HbA(1c)), diurnal glucose profiles and hypoglycaemia in patients with Type 2 diabetes treated with the combination of basal insulin and metformin. RESEARCH DESIGN AND METHODS: This was an investigator-initiated, double-blind, randomized, parallel-group, study in five centres. Patients with Type 2 diabetes (n = 88, age 56.0 +/- 0.9 years, duration of diabetes 9.4 +/- 0.5 years, HbA(1c) 7.8 +/- 0.1%, body mass index 32.4 +/- 0.5 kg/m(2)) treated with basal insulin and metformin entered a 24-week period, during which basal insulin was titrated to optimize glucose control. Thereafter, the patients were randomized to receive either nateglinide (120 mg three times daily) or placebo before their main meals for 24 weeks. RESULTS: During the optimization period, HbA(1c) decreased by -0.3 +/- 0.1 and -0.4 +/- 0.2% (NS) and insulin doses increased by 10.0 IU (2.0-32.0) [0.09 IU/kg (0.02-0.34)] and 10.0 IU (0.0-19.0) [0.11 IU/kg (0.0-0.25)] (NS) in the nateglinide and placebo groups. Mean postprandial glucose during weeks 20-24 averaged 9.0 +/- 0.3 and 10.0 +/- 0.3 mmol/l in the nateglinide and placebo groups (P = 0.025) and mean PPGE averaged 2.4 +/- 0.2 and 3.1 +/- 0.2 mmol/l, respectively (P = 0.019). At 24 weeks as compared with 0 weeks, mean HbA(1c) had decreased by 0.41 +/- 0.12% in the nateglinide group and by 0.04 +/- 0.12% in the placebo group (P = 0.023). The frequency of confirmed, symptomatic hypoglycaemia was 7.7 episodes/patient-year vs. 4.7 episodes/patient-year in the nateglinide and placebo groups (P = 0.031). CONCLUSIONS: Addition of a short-acting insulin secretagogue at main meals improves postprandial hyperglycaemia during combination therapy with basal insulin and metformin, but increases the frequency of hypolycaemia.
Subject(s)
Cyclohexanes/administration & dosage , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Metformin/administration & dosage , Phenylalanine/analogs & derivatives , Adult , Aged , Drug Administration Schedule , Drug Therapy, Combination , Female , Glycated Hemoglobin/drug effects , Humans , Hypoglycemia/drug therapy , Male , Middle Aged , Nateglinide , Phenylalanine/administration & dosage , Postprandial Period , Young AdultABSTRACT
A retrospective study supplemented with follow-up was carried out in 163 children, aged 6 months to 16 years, who were hospitalized because of acute, recurrent or chronic urticaria in 1976-1980. Etiologic agents were identified in 55% of cases. Physical factors were the commonest causes, especially in cases of chronic urticaria, while infections predominated in acute urticaria. 81% of the children participated in the follow-up study. Follow-up for a year or more revealed that 53% of the children had become symptom-free, 36% still had symptoms but less frequently and in 11% urticaria was unresolved. The results indicate that the etiologic factors in childhood urticaria are similar to those found in adults and that prognosis is favorable, particularly when the etiology is established.
