Dermagraft was associated with more complete and rapid healing in diabetic foot ulcers. The recurrence data may indicate an improved quality of wound healing.
OBJECTIVE -Glycemic control using inhaled, dry-powder insulin plus a single injection of long-acting insulin was compared with a conventional regimen in patients with type 2 diabetes, which was previously managed with at least two daily insulin injections.RESEARCH DESIGN AND METHODS -Patients were randomized to 6 months' treatment with either premeal inhaled insulin plus a bedtime dose of Ultralente (n ϭ 149) or at least two daily injections of subcutaneous insulin (mixed regular/NPH insulin; n ϭ 150). The primary efficacy end point was the change in HbA 1c from baseline to the end of study.RESULTS -HbA 1c decreased similarly in the inhaled (Ϫ0.7%) and subcutaneous (Ϫ0.6%) insulin groups (adjusted treatment group difference: Ϫ0.07%, 95% CI Ϫ0.32 to 0.17). HbA 1c Ͻ7.0% was achieved in more patients receiving inhaled (46.9%) than subcutaneous (31.7%) insulin (odds ratio 2.27, 95% CI 1.24 -4.14). Overall hypoglycemia (events per subject-month) was slightly lower in the inhaled (1.4 events) than in the subcutaneous (1.6 events) insulin group (risk ratio 0.89, 95% CI 0.82-0.97), with no difference in severe events. Other adverse events, with the exception of increased cough in the inhaled insulin group, were similar. No difference in pulmonary function testing was seen. Further studies are underway to assess tolerability in the longer term. Insulin antibody binding increased more in the inhaled insulin group. Treatment satisfaction was greater in the inhaled insulin group.CONCLUSIONS -Inhaled insulin appears to be effective, well tolerated, and well accepted in patients with type 2 diabetes and provides glycemic control comparable to a conventional subcutaneous regimen.
The present study was a 52-week extension of a previously published, multi-center, randomized, parallel-group study. The aim of this extension study was to compare the efficacy and tolerability of vildagliptin and metformin in drug-naïve patients with type 2 diabetes over 104 weeks. The extension population comprised 305 patients randomized to vildagliptin (100 mg daily) and 158 patients randomized to metformin (2 000 mg daily). Pioglitazone was added as rescue medication if fasting glucose was >10 mmol/l; data from patients receiving rescue medication were excluded from the primary analysis. Baseline HbA (1c) averaged 8.4+/-0.1% in patients randomized to vildagliptin and 8.8+/-0.1% in those randomized to metformin. The adjusted mean change from baseline to study endpoint was -1.0+/-0.1% in vildagliptin-treated patients and -1.5+/-0.1% in those receiving metformin (p<0.001 vs. vildagliptin). These results were similar to those reported after the 1-year core phase of the study. The adjusted mean changes in body weight from baseline to endpoint were 0.5+/-0.4 kg and -2.5+/-0.5 kg in the vildagliptin and metformin groups, respectively. One or more adverse event (AE) was reported by 82.2% of patients receiving vildagliptin and by 87.3% of those receiving metformin (p<0.001). Gastrointestinal AEs were more common in patients receiving metformin (45.6%) than in those receiving vildagliptin (25.0%, p<0.001 vs. metformin). One hypoglycemic event occurred after strenuous exercise in a single patient receiving vildagliptin (0.3%). In conclusion, both vildagliptin and metformin monotherapy provided clinically meaningful decreases in HbA (1c) over 2 years in drug-naïve patients with type 2 diabetes. Vildagliptin was weight neutral, while weight loss was observed with metformin; however, metformin was associated with significantly worse gastrointestinal tolerability.
This study was undertaken to characterize bile acid metabolism in hereditary forms of hypertriglyceridemia. Ten hypertriglyceridemic patients (type IV phenotype) with familial combined hyperlipidemia and 7 patients with monogenic familial hypertriglyceridemia (FHTG) were compared with 18 healthy controls; all subjects were males. Pool size, synthesis rate, and fractional catabolic rate of cholic and chenodeoxycholic acids were determined with an isotope dilution technique. Patients with FHTG had synthesis rates of cholic acid, chenodeoxycholic acid, and total bile acids above those seen in normal controls (P < 0.001); also the fractional catabolic rates of both bile acids were increased (P < 0.001). In contrast, bile acid kinetic parameters were-with one exception-within normal limits in patients with familial combined hyperlipidemia. The abnormality of bile acid metabolism could also be identified in a normolipidemic individual presumed to carry the gene for FHTG. The postprandial rise of serum bile acids was blunted in FHTG, indicating that the intestinal uptake of bile acids may be deficient in this condition. We conclude that FHTG, but not familial combined hyperlipidemia, is frequently associated with a defective regulation of bile acid synthesis, resulting in an abnormally high production rate of bile acids. It is hypothesized that this abnormality is important for the subsequent development of hypertriglyceridemia.
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