Efficacy of inhaled insulin in patients with type 2 diabetes not controlled with diet and exercise: a 12-week, randomized, comparative trial.

OBJECTIVE: Effective type 2 diabetes management requires prompt intervention if glycemic control is not achieved by nonpharmacological means. This study investigates whether inhaled insulin (INH; Exubera) can achieve target glycemic control in patients failing on diet and exercise. RESEARCH DESIGN AND METHODS: Patients with suboptimal control on diet and exercise (HbA(1c) [A1C] 8-11%) were randomized to 3 months' treatment with either INH before meals (n = 76) or rosiglitazone 4 mg twice a day (n = 69), in conjunction with a diet and exercise regimen. The primary end point was percentage of patients achieving A1C <8.0%. RESULTS: The INH and rosiglitazone groups had comparable baseline A1C values (9.5 vs. 9.4%, respectively). Significantly more patients achieved A1C <8.0% (83 vs. 58%, adjusted odds ratio 7.14 [95% CI 2.48-20.58], P = 0.0003), A1C <7.0% (44 vs. 18%, 4.43 [1.94-10.12]), and A1C < or = 6.5% (28 vs. 7.5% 5.34 [1.83-15.57]) with INH. A1C decrease was greater with INH (-2.3% vs. -1.4%, adjusted treatment group difference: -0.89% [95% CI -1.23 to -0.55]) with final mean A1C values of 7.2 and 8.0% for INH and rosiglitazone, respectively. Hypoglycemia (episodes per subject-month) was higher with INH (0.7 vs. 0.05, risk ratio 14.72 [95% CI 7.51-28.83]), with no severe hypoglycemic episodes. Pulmonary function changes were small and comparable between groups. CONCLUSIONS: INH could be an effective therapy for people with type 2 diabetes early in the course of their disease.

Effects of Xuezhikang in patients with dyslipidemia: a multicenter, randomized, placebo-controlled study.

BACKGROUND: Xuezhikang (XZK) is an extract of fermented red yeast rice that has lipid-lowering properties. OBJECTIVE: To evaluate the effects of XZK on lipids in subjects with dyslipidemia but no coronary heart disease. METHODS: A total of 116 adults with baseline non-high-density lipoprotein cholesterol (non-HDL-C) levels of approximately 208 mg/dL and low-density lipoprotein cholesterol (LDL-C) levels of approximately 175 mg/dL were randomized to either placebo or XZK 1200 or 2400 mg daily and treated for 12 weeks. RESULTS: A majority of the patients were white (53.4%) or Asian (37.1%). Daily XZK 1200 mg and 2400 mg for 4 to 12 weeks resulted in statistically significant (P < .001) and clinically meaningful decreases in non-HDL-C (∼24% reduction) and LDL-C (∼27% reduction) compared with placebo. XZK treatment at either dose enabled approximately 50% of subjects to reduce their LDL-C levels by ≥ 30%. Doubling the XZK daily dose from 1200 to 2400 mg at treatment week 8 caused an additional 4.6% reduction in LDL-C. Significant benefits were also observed across secondary efficacy variables, including total cholesterol (TC), apolipoprotein B (Apo B), triglycerides, HDL-C, the TC/HDL-C ratio, and the Apo B/Apo A-I ratio, at treatment week 8 or 12. XZK was safe and well tolerated. Safety and tolerability profiles were similar across treatment groups. Most adverse events were gastrointestinal. No subject experienced myopathy or markedly elevated liver transaminases or creatine kinase. CONCLUSION: Xuezhikang significantly reduced non-HDL-C and LDL-C, and was well tolerated. Further, longer-term studies in more diverse patient populations are needed to corroborate these findings.