Efficacy and safety of teneligliptin, a dipeptidyl peptidase-4 inhibitor, combined with metformin in Korean patients with type 2 diabetes mellitus: a 16-week, randomized, double-blind, placebo-controlled phase III trial.

The aim of the present study was to assess the efficacy and safety of teneligliptin in combination with metformin in Korean patients with type 2 diabetes mellitus who were inadequately controlled with metformin monotherapy. Patients [glycated haemoglobin (HbA1c) 7.0-10.0%, on stable metformin ≥1000 mg/day] were randomized 2 : 1 to receive 20 mg teneligliptin plus metformin (n = 136) or placebo plus metformin (n = 68). The primary endpoint was the change in HbA1c levels from baseline to week 16. The mean baseline HbA1c was 7.9% in the teneligliptin group and 7.8% in the placebo group. The differences between the teneligliptin and placebo groups regarding changes in HbA1c and fasting plasma glucose levels were -0.78 % and -1.24 mmol/l (22.42 mg/dl), respectively, at week 16. The incidence of adverse events was similar between the groups. The addition of teneligliptin once daily to metformin was effective and generally well tolerated in Korean patients with type 2 diabetes.

Anagliptin and sitagliptin as add-ons to metformin for patients with type 2 diabetes: a 24-week, multicentre, randomized, double-blind, active-controlled, phase III clinical trial with a 28-week extension.

We conducted a 24-week, multicentre, double-blind, randomized study with a 28-week extension to compare the efficacy and safety of anagliptin and sitagliptin as an add-on to metformin in patients with type 2 diabetes. Patients inadequately controlled on metformin were randomized to either anagliptin (100 mg twice daily, n = 92) or sitagliptin (100 mg once daily, n = 88). The primary endpoint was the change in glycated haemoglobin (HbA1c) from baseline to week 24. The mean changes in HbA1c were -0.85 ± 0.70% (p < 0.0001) for anagliptin and -0.83 ± 0.61% (p < 0.0001) for sitagliptin, with a mean difference of -0.02% (95% confidence interval of difference, -0.22 to 0.18%). In both groups, the fasting proinsulin : insulin ratio significantly decreased from baseline, with improved insulin secretion. Safety profiles were similar in each group. In conclusion, the non-inferiority of the efficacy of anagliptin to sitagliptin as an add-on therapy was established with regard to efficacy and safety.

Comparison of the efficacy and safety of tramadol/acetaminophen combination therapy and gabapentin in the treatment of painful diabetic neuropathy.

AIMS: This study compared the efficacy and safety of tramadol/acetaminophen (T/A) and gabapentin in the management of painful diabetic neuropathy. METHODS: An open, randomized, comparative study was conducted. Subjects with painful symmetric neuropathy in the lower limbs and mean pain-intensity score > or = 4 on a numeric rating scale were eligible. Subjects were randomized to receive either tramadol (37.5 mg)/acetaminophen (325 mg) or gabapentin (300 mg) for 6 weeks. After 2 weeks of the titration period (1200 mg/day for gabapentin and three tablets/day for T/A), the doses were maintained if the pain was relieved. The primary efficacy outcome was a reduction in pain intensity. Secondary measures evaluated a pain relief scale, a Brief Pain Inventory, a 36-item Short Form Health Survey, average pain intensity and sleep disturbance. RESULTS: One hundred and sixty-three subjects (T/A 79; gabapentin 84) were included. At the final visit, the mean doses were 1575 mg/day for gabapentin and 4.22 tablets/day for T/A. Both groups were similar in terms of baseline pain intensity (mean intensity: T/A 6.7 +/- 1.6; gabapentin 6.3 +/- 1.6, P = 0.168). At the final visit, the mean reductions in pain intensity were similar in both groups (T/A -3.1 +/- 2.0; gabapentin -2.7 +/- 2.1, P = 0.744). Both groups had similar improvements in every Short Form Health Survey category and Brief Pain Inventory subcategory, and in the mean pain relief scores. CONCLUSION: This study suggests that the T/A combination treatment is as effective as gabapentin in the treatment of painful diabetic neuropathy in patients with Type 2 diabetes.

BCG vaccine prevents insulitis in low dose streptozotocin-induced diabetic mice.

Autoimmune type 1 diabetes mellitus is caused by the immunologic destruction of pancreatic beta-cells; therefore, there have been many attempts at immunologic modulation as a block or prevention of the underlying process. The aim of this study is to investigate the effect of BCG vaccination on low dose streptozotocin-induced diabetic (LDSD) mice. The mice were pretreated with BCG 7 days before starting low dose streptozotocin (STZ), observed body weight and blood glucose for 2 months, then analyzed the severity of the STZ-induced insulitis after the animals were sacrificed. In this experiment, the mean body weights in the BCG-STZ group on days 1, 19, 33, 47, and 61 of the experiment were 37.5 +/- 3.6, 37.3 +/- 3.6, 37.5 +/- 3.5, 39.4 +/- 3.9, and 39.3 +/- 4.5 (g), respectively. Those in the STZ group were 37.7 +/- 3.5, 38.3 +/- 4.5, 38.4 +/- 3.9, 36.2 +/- 4.5, and 36.3 +/- 4.0 (g), respectively (P < 0.05). The mean blood glucose levels in the BCG-STZ group on days 1, 19, 33, 47, and 61 were 106.5 +/- 8, 150 +/- 37, 147 +/- 54, 143 +/- 60, and 142 +/- 66 (mg/dl), respectively. Those in the STZ group were 103 +/- 12, 196 +/- 90, 261 +/- 236, 236 +/- 91, and 224 +/- 89 (mg/dl), respectively (P < 0.05). The numbers developing grade 0, I, II, III, and IV insulitis in the BCG-treated group were 63, 48, 33, 4, and 2, respectively, and in the control group were 16, 23, 31, 45, and 35, respectively. This study indicates that BCG vaccination reduces the development of insulitis and overt diabetes in LDSD mice.

Relation between insulin resistance and hematological parameters in elderly Koreans-Southwest Seoul (SWS) Study.

In this study, we investigated the relation between insulin resistance and hematological parameters in elderly Koreans. This study included 1314 non-diabetic subjects over the age of 60, selected from a cross-sectional study, which was conducted in 1999 in Seoul, Korea. We measured fasting and post-load 2 h plasma glucose, insulin levels, lipid profiles, anthropometric measures, and hematological parameters. The degree of insulin resistance was assessed using the homeostasis model assessment (HOMA). We found a correlation between insulin resistance and hemoglobin concentrations in non-smoking men (r=0.20, P=0.0186). In non-smoking women, insulin resistance correlated with hemoglobin (r=0.10, P=0.0017) and with white blood cell (WBC) count (r=0.15, P=0.001). Hemoglobin concentrations and WBC counts were also associated with other components of the insulin resistance syndrome such as body mass index, blood pressure, lipid profiles and fasting plasma insulin levels (surrogate for insulin resistance). Furthermore, the group in the upper quartile for insulin resistance showed higher hemoglobin concentrations and WBC counts than the lower quartile, independent of smoking status and serum iron concentrations. Using HOMA-IR as a dependent variable in a multiple regression analysis, age, body mass index (BMI), waist-to-hip ratio (WHR), systolic blood pressure, HDL cholesterol, triglyceride, WBC count, hemoglobin, hematocrit and serum TIBC were significant. Our results provide support for a relation between insulin resistance/hyperinsulinemia and hematological parameters such as hemoglobin concentrations and WBC counts in elderly Koreans. This suggests that increased erythropoiesis and subclinical inflammation could be part of the metabolic syndrome in elderly Koreans.

Will your patient admit "he hits me"?

Family violence is typically progressive. As a man realizes the effectiveness of physical and emotional coercion, he tends to use it more frequently. In the face of imbalance of power in the relationship, a victim becomes more fearful, more submissive, and more likely to face serious injury. This is the first of a two-part series on physicians helping patients cope with domestic violence.

Use of a real time continuous glucose monitoring system as a motivational device for poorly controlled type 2 diabetes.

OBJECTIVE: The use of a real time continuous glucose monitoring system (RT-CGM) was studied as a behavior modification tool and the effectiveness of a RT-CGM in glucose control for patients with type 2 diabetes was determined. METHODS: We conducted a prospective, open-label, randomized, controlled clinical trial in 65 patients with poorly controlled type 2 diabetes (8.0

A case of adrenocortical tumor coexisted with paragangliomas.

We report a case of adrenocortical tumor that coexisted with paragangliomas. A 35-year-old woman was admitted to the hospital because of left upper abdominal pain. A palm-sized mass was palpated at left upper quadrant. Hormonal studies revealed the features of pheochromocytoma. An emergency operation was performed because hemorrhage of the tumor was suspected. A 10 cm diameter ruptured mass was found in the left adrenal area and other tumors were also noted adjacent to inferior vena cava (IVC). The pathologic report revealed that the adrenal mass was an adrenocortical tumor with hemorrhagic necrosis and that the tumors adjacent to IVC were paragangliomas. This was the first case of adrenocortical tumor with paragangliomas in our Medline search result, hence we report the case with a review of the literature.

Factor analysis of the metabolic syndrome among elderly Koreans--the South-west Seoul Study.

AIMS: To examine the relationship between the components of the metabolic syndrome and to explore whether insulin resistance unifies the clustering of components of the metabolic syndrome among urban elderly Koreans using exploratory factor analysis. METHODS: We included 1314 non-diabetic subjects over the age of 60 years, selected from a cross-sectional study, which was conducted in 1999 in Seoul, Korea. Factor analysis was carried out using the principle components analysis with Varimax orthogonal rotation of the components of the metabolic syndrome. RESULTS: We found four major factors of cardiovascular disease risk variables in our study subjects. Impaired glucose tolerance, dyslipidaemia, hypertension and obesity aggregated as the major domain. Obesity and dyslipidaemia variables were closely related and loaded on the same factor. However, hypertension was not linked closely with other factors of the metabolic syndrome. CONCLUSIONS: Insulin resistance is not the only contributor to the metabolic syndrome among urban elderly Koreans. Although the components of the metabolic syndrome were closely related, the finding of more than one factor suggests that more than one pathophysiological mechanism underlies full expression of the metabolic syndrome among elderly Koreans.

Comparison of ADA and WHO criteria for the diagnosis of diabetes in elderly Koreans.

AIMS: This study was conducted to compare the prevalence and cardiovascular risk factors of different categories of glucose tolerance in the elderly Korean population using World Health Organization (WHO) and American Diabetes Association (ADA) criteria. METHODS: This study included 1456 non-diabetic subjects over the age of 60 years, selected from a cross-sectional study, which was conducted in 1999 in Seoul, Korea. Fasting and post-challenge 2-h plasma glucose, insulin levels, body mass index (BMI), waist-hip ratio (WHR), blood pressure, and lipid profiles were examined. Prevalence of glucose tolerance categories and the level of agreement (kappa statistics) were obtained using WHO 2-h criteria and ADA fasting criteria. Comparison of cardiovascular risk factors among several concordant and discordant glucose intolerance groups was done. RESULTS: The prevalence rates of newly diagnosed diabetes of elderly men defined by WHO 2-h criteria and ADA fasting criteria were 11.8% and 4.8%, respectively. That of elderly women was 8.1% by WHO 2-h criteria and 3.1% by ADA fasting criteria. The prevalence of impaired glucose tolerance (IGT) by WHO criteria was also higher than that of impaired fasting glucose (IFG) by ADA criteria (23.5% vs. 10.0% men, 23.7% vs. 7.5% women). The level of agreement between ADA fasting criteria and WHO 2-h criteria was low (weighted kappa = 0.228 men, weighted kappa = 0.301 women). The concordant diabetic women by both ADA fasting criteria and WHO 2-h criteria showed higher BMI, WHR, diastolic blood pressure, total cholesterol and triglyceride levels than concordant normal subjects. However, the isolated post-challenge hyperglycaemia (IPH) women group was not different significantly from the concordant normal women group except in BMI. CONCLUSIONS: Our results clearly show that the 1997 ADA fasting criteria are less sensitive for diagnosing diabetes than oral glucose tolerance test (OGTT)-based WHO criteria in elderly Koreans. Also, there is a poor agreement of different categories of glucose tolerance between ADA and WHO criteria; therefore, the OGTT remains a valuable test in diagnosing diabetes and classifying various categories of glucose intolerance, especially in elderly Koreans.