The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (–0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was –0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was –0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.

The purpose of this extension study was to assess the long-term efficacy and safety of gemigliptin 50 mg in patients with type 2 diabetes mellitus (T2DM). Patients with T2DM who had completed the initial 24-week study comparing gemigliptin monotherapy with placebo were eligible to enrol. In the open-label, 28-week extension study, all enrolled patients received gemigliptin, regardless of the treatment received during the initial 24-week study period. The mean reduction±standard deviation (SD) in glycosylated hemoglobin (HbA1c) observed after 24 weeks of treatment (–0.6%±1.1%) was further decreased for the gemi-gemi group and the mean change in HbA1c at week 52 from baseline was –0.9%±1.2% (P<0.0001). For the pbo-gemi group, HbA1c decreased after they were switched to gemigliptin, and the mean change in HbA1c at week 52 from baseline was –0.7%±1.2% (P<0.0001). Furthermore, the overall incidence of adverse events demonstrated that gemigliptin was safe and well tolerated up to 52 weeks.

BACKGROUND: Combination of metformin to reduce the fasting plasma glucose level and an α-glucosidase inhibitor to decrease the postprandial glucose level is expected to generate a complementary effect. We compared the efficacy and safety of a fixed-dose combination of voglibose plus metformin (vogmet) with metformin monotherapy in drug-naïve newly-diagnosed type 2 diabetes mellitus. METHODS: A total of 187 eligible patients aged 20 to 70 years, with a glycosylated hemoglobin (HbA1c) level of 7.0% to 11.0%, were randomized into either vogmet or metformin treatments for 24 weeks. A change in the HbA1c level from baseline was measured at week 24. RESULTS: The reduction in the levels of HbA1c was −1.62%±0.07% in the vogmet group and −1.31%±0.07% in the metformin group (P=0.003), and significantly more vogmet-treated patients achieved the target HbA1c levels of <6.5% (P=0.002) or <7% (P=0.039). Glycemic variability was also significantly improved with vogmet treatment, estimated by M-values (P=0.004). Gastrointestinal adverse events and hypoglycemia (%) were numerically lower in the vogmet-treated group. Moreover, a significant weight loss was observed with vogmet treatment compared with metformin (−1.63 kg vs. −0.86 kg, P=0.039). CONCLUSION: Vogmet is a safe antihyperglycemic agent that controls blood glucose level effectively, yields weight loss, and is superior to metformin in terms of various key glycemic parameters without increasing the risk of hypoglycemia.
Blood Glucose ; Diabetes Mellitus, Type 2 ; Fasting ; Glucose ; Hemoglobin A, Glycosylated ; Humans ; Hypoglycemia ; Metformin ; Weight Loss

BACKGROUND/AIMS: This nationwide, multicenter prospective randomized controlled trial aimed to compare the efficacy and safety of 10-day concomitant therapy (CT) and 10-day sequential therapy (ST) with 7-day clarithromycin-containing triple therapy (TT) as first-line treatment for Helicobacter pylori infection in the Korean population. METHODS: Patients with H. pylori infection were assigned randomly to 7d-TT (lansoprazole 30 mg, amoxicillin 1 g, and clarithromycin 500 mg twice daily for 7 days), 10d-ST (lansoprazole 30 mg and amoxicillin 1 g twice daily for the first 5 days, followed by lansoprazole 30 mg, clarithromycin 500 mg, and metronidazole 500 mg twice daily for the remaining 5 days), or 10d-CT (lansoprazole 30 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg twice daily for 10 days). The primary endpoint was eradication rate by intention-to-treat (ITT) and per-protocol (PP) analyses. RESULTS: A total of 1,141 patients were included. The 10d-CT protocol achieved a markedly higher eradication rate than the 7d-TT protocol in both the ITT (81.2% vs 63.9%) and PP analyses (90.6% vs 71.4%). The eradication rate of the 10d-ST protocol was superior to that of the 7d-TT protocol (76.3% vs 63.9%, ITT analysis; 85.0% vs 71.4%, PP analysis). No significant differences in adherence or serious side effects were found among the three treatment arms. CONCLUSIONS: The 10d-CT and 10d-ST regimens were superior to the 7d-TT regimen as standard first-line treatment in Korea.
Amoxicillin ; Arm ; Clarithromycin ; Disease Eradication ; Helicobacter pylori ; Helicobacter ; Humans ; Korea ; Lansoprazole ; Metronidazole ; Prospective Studies

BACKGROUND: Hepatitis B virus (HBV) infection leads to hepatic and extrahepatic manifestations including chronic kidney disease (CKD). However, the association between HBV and CKD is not clear. This study investigated the association between chronic HBV infection and CKD in a nationwide multicenter study. METHODS: A total of 265,086 subjects who underwent health-check examinations in 33 hospitals from January 2015 to December 2015 were enrolled. HBV surface antigen (HBsAg) positive cases (n = 10,048), and age- and gender-matched HBsAg negative controls (n = 40,192) were identified. CKD was defined as a glomerular filtration rate (GFR) < 60 mL/min/1.73 m² or proteinuria as at least grade 2+ of urine protein. RESULTS: HBsAg positive cases showed a significantly higher prevalence of GFR < 60 mL/min/1.73 m² (3.3%), and proteinuria (18.9%) than that of the controls (2.6%, P < 0.001, and 14.1%, P < 0.001, respectively). In the multivariate analysis, HBsAg positivity was an independent factor associated with GFR < 60 mL/min/1.73 m² along with age, blood levels of albumin, bilirubin, anemia, and hemoglobin A1c (HbA1c). Likewise, HBsAg positivity was an independent factor for proteinuria along with age, male, blood levels of bilirubin, protein, albumin, and HbA1c. A subgroup analysis showed that HBsAg positive men but not women had a significantly increased risk for GFR < 60 mL/min/1.73 m². CONCLUSION: Chronic HBV infection was significantly associated with a GFR < 60 mL/min/1.73 m² and proteinuria (≥ 2+). Therefore, clinical concern about CKD in chronic HBV infected patients, especially in male, is warranted.
Anemia ; Antigens, Surface ; Bilirubin ; Case-Control Studies* ; Female ; Glomerular Filtration Rate ; Hepatitis B Surface Antigens ; Hepatitis B virus ; Hepatitis B, Chronic* ; Hepatitis, Chronic* ; Humans ; Male ; Multivariate Analysis ; Prevalence ; Proteinuria ; Renal Insufficiency, Chronic*

BACKGROUND/AIMS: We evaluated whether colonic transit time (CTT) can predict the degree of bowel preparation in patients with chronic constipation undergoing scheduled colonoscopy in order to assist in the development of better bowel preparation strategies for these patients. METHODS: We analyzed the records of 160 patients with chronic constipation from March 2007 to November 2012. We enrolled patients who had undergone a CTT test followed by colonoscopy. We defined patients with a CTT > or =30 hours as the slow transit time (STT) group, and patients with a CTT <30 hours as the normal transit time (NTT) group. Boston Bowel Preparation Scale (BBPS) scores were compared between the STT and NTT groups. RESULTS: Of 160 patients with chronic constipation, 82 (51%) were included in the STT group and 78 (49%) were included in the NTT group. Patients with a BBPS score of <6 were more prevalent in the STT group than in the NTT group (31.7% vs. 10.3%, P=0.001). Multivariate analysis showed that slow CTT was an independent predictor of inadequate bowel preparation (odds ratio, 0.261; 95% confidence interval, 0.107-0.634; P=0.003). The best CTT cut-off value for predicting inadequate bowel preparation in patients with chronic constipation was 37 hours, as determined by receiver operator characteristic (ROC) curve analysis (area under the ROC curve: 0.676, specificity: 0.735, sensitivity: 0.643). CONCLUSIONS: Patients with chronic constipation and a CTT >30 hours were at risk for inadequate bowel preparation. CTT measured prior to colonoscopy could be useful for developing individualized strategies for bowel preparation in patients with slow CTT, as these patients are likely to have inadequate bowel preparation.
Colon* ; Colonoscopy ; Constipation* ; Humans ; Multivariate Analysis ; ROC Curve ; Sensitivity and Specificity

BACKGROUND: The Korean National Diabetes Program (KNDP) cohort study is performing an ongoing large-scale prospective multicenter investigation to discover the pathogenesis of type 2 diabetes in Korean patients. This study was performed to examine the prevalence of chronic complications in patients with type 2 diabetes among those registered in the KNDP cohort within the past 4 years. METHODS: This study was performed between June 2006 and September 2009 at 13 university hospitals and included 4,265 KNDP cohort participants. Among the participants, the crude prevalence of microvascular and macrovascular diseases of those checked for diabetes-related complications was determined, and the adjusted standard prevalence and standardization of the general population prevalence ratio (SPR) was estimated based on the 2005 Korean National Health and Nutrition Examination Survey (KNHANES) population demographics. RESULTS: Among the KNDP registrants, 43.2% had hypertension, 34.8% had dyslipidemia, 10.8% had macrovascular disease, and 16.7% had microvascular disease. The SPR of the KNDP registrants was significantly higher than that of the KNHANES subjects after adjusting for demographics in the KNHANES 2005 population. However, with the exception of cardiovascular disease in females, the standardized prevalence for the most complicated items in the survey was significantly higher than that in the KNHANES subjects. CONCLUSION: The prevalence of macrovascular disease and peripheral vascular disease were significantly higher in Korean patients with type 2 diabetes than in the normal population. However, no significant difference was noted in the prevalence of cardiovascular disease in females.
Cardiovascular Diseases ; Cerebrovascular Disorders ; Cohort Studies ; Coronary Disease ; Demography ; Diabetes Complications ; Diabetes Mellitus, Type 2 ; Diabetic Retinopathy ; Dyslipidemias ; Female ; Hospitals, University ; Humans ; Hypertension ; Korea ; Nutrition Surveys ; Peripheral Vascular Diseases ; Prevalence ; Prospective Studies

No abstract available.

No Abstract Available.

BACKGROUND/AIMS: The extraction of large common bile duct (CBD) stones after an endoscopic sphincterotomy (EST) is successful in 80~90% of cases but it often requires a prolonged time and repeated trials. This study investigated the utility of a combined endoscopic papillary large balloon dilatation (EPLBD) and a mid-incision of an EST (m-EST) method for the removal of large CBD stones. METHODS: Thirty patients with large CBD stones were enrolled in this study. EPLBD was carried out using the one-step inflation of a 15~18 mm diameter balloon after m-EST. RESULTS: The maximum stone diameter was 21.62+/-5.38 mm. Twelve patients had more than 4 stones, 7 patients had 2 stones, and the remainder had a single large stone. Complete ductal clearance was achieved in all patients. After the procedure, the serum amylase and/or lipase levels were elevated in 3 patients (13.3%). However, there was no episode of true pancreatitis. Minor bleeding was encountered in only one patient (3.3%), and was easily controlled by an endoscopic epinephrine injection. The procedure was carried out safely in 6 patients with periampullary diverticulum. No perforation or mortality was encountered. CONCLUSIONS: Combined EPLBD and m-EST is a safe and effective method, and may be a good alternative treatment for removing large CBD stones.
Amylases ; Bile Ducts* ; Bile* ; Choledocholithiasis ; Common Bile Duct ; Dilatation* ; Diverticulum ; Epinephrine ; Hemorrhage ; Humans ; Inflation, Economic ; Lipase ; Mortality ; Pancreatitis ; Sphincterotomy, Endoscopic*