Addition of Ipragliflozin to Metformin Treatment in Korean Patients with Type 2 Diabetes Mellitus: Subgroup Analysis of a Phase 3 Trial

BACKGROUND: This is a subgroup analysis of Korean patients from a phase 3 clinical trial investigating the efficacy and safety of ipragliflozin in patients with type 2 diabetes mellitus inadequately controlled with metformin. METHODS: This multicenter, placebo-controlled, double-blind, parallel-group study was carried out between November 2011 and January 2013. Patients entered a 2-week placebo pretreatment period, followed by a 24-week treatment period with either ipragliflozin (50 mg/day) or placebo, while continuing metformin. Efficacy outcomes (glycosylated hemoglobin [HbA1c], fasting plasma glucose [FPG], and body weight) and safety outcomes (treatment-emergent adverse events [TEAEs]) were measured and compared between the two treatment groups for patients enrolled in all 18 study sites in Korea. RESULTS: Eighty-two Korean patients received ipragliflozin (n=43) or placebo (n=39) during the study period. Mean changes in HbA1c levels from baseline to the end of treatment were –0.97% in the ipragliflozin group and –0.31% in the placebo group, with an adjusted between-group difference of –0.60% (P<0.001). Compared to placebo, FPG and body weight also decreased significantly (both P<0.001) from baseline after treatment in the ipragliflozin group, with between-group differences of –21.4 mg/dL and –1.53 kg, respectively. Decreased weight was the most common TEAE in the ipragliflozin group (7.0%); there were no reports of genital and urinary tract infection. CONCLUSION: Ipragliflozin treatment in addition to metformin led to significant improvement in glycemic outcomes and reduction in body weight in Korean patients with type 2 diabetes mellitus, compared with metformin treatment alone; the safety profile was comparable in both groups.

Facilitation of web-based internet PBL: What is an adequate group size?

Background: Development in internet technology enables e-learning at the higher education level. We have developed the Internet PBL-Tutorial System/Rakuichi that allows multi-directional communication among participants with web-based bulletin boards. Although this system has been successful in medical education at the undergraduate level, we sought to encourage “readonly members” to participate more fully in the program. Methods: To this end, we compared the posting frequency among three strategies: (1) students and tutors had an off-site meeting to promote face-to-face communication during the course, (2) several classes were allowed to watch the discussion in other classes in the second half of the course, (3) three classes (5 – 6 students each) in one topic were combined into one class (16 students) in the second half. Results: No meaningful effects were observed for strategies (1) or (2). However, the posting frequency increased 50 % for strategy (3). Conclusion: Facilitation of communication among participants was achieved by increasing the number of student participants. We predicted that an optimal number of students in each class in internet-based PBL would be ~20 people.

Autoimmune Pancreatitis Developing Remarkable Collateral Circulation Around the Pancreas / Journal of Rural Medicine

A 65-year-old man was referred to our hospital in April 2003 with a pancreas tumor detected by a thorough medical checkup. Computed tomography (CT) showed swelling of the pancreatic body and tail, and magnetic resonance cholangiopancreatography (MRCP) showed only the main pancreatic duct in the head of the pancreas. Diagnosing autoimmune pancreatitis, we observed the patient without medication. However, one year later CT showed stenosis of the splenic artery and portal vein accompanied by development of collateral circulation around the pancreas. He had no symptoms, and CT showed no changes in the pancreatic swelling.;;He was admitted to our hospital on January 6, 2005, presenting with a history of jaundice which first appeared on January 1, 2005, and increased collateral circulation around the pancreas with pancreatic swelling were seen on CT. We started prednisolone therapy at 40 mg/day for exacerbation of autoimmune pancreatitis. Serum bilirubin levels improved from 11.9 mg/dl to 2.5 mg/dl, and pancreatic swelling also improved four weeks after starting therapy.;;We present a rare case of autoimmune pancreatitis that developed marked collateral circulations.