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https://www.readbyqxmd.com/read/28727908/leveraging-a-clinical-phase-ib-proof-of-concept-study-for-the-gpr40-agonist-mk-8666-in-patients-with-type-2-diabetes-for-model-informed-phase-ii-dose-selection
#1
A W Krug, P Vaddady, R A Railkar, B J Musser, J Cote, Agh Ederveen, D G Krefetz, E DeNoia, A L Free, L Morrow, M V Chakravarthy, E Kauh, D A Tatosian, P A Kothare
GPR40 mediates free fatty acid-induced insulin secretion in beta cells. We investigated the safety, pharmacokinetics, and glucose response of MK-8666, a partial GPR40 agonist, after once-daily multiple dosing in type 2 diabetes patients. This double-blind, multisite, parallel-group study randomized 63 patients (placebo, n = 18; 50 mg, n = 9; 150 mg, n = 18; 500 mg, n = 18) for 14-day treatment. The results showed no serious adverse effects or treatment-related hypoglycemia. One patient (150-mg group) showed mild-to-moderate transaminitis at the end of dosing...
July 20, 2017: Clinical and Translational Science
https://www.readbyqxmd.com/read/28722480/efficacy-and-safety-of-biosimilar-sar342434-insulin-lispro-in-adults-with-type-1-diabetes-also-using-insulin-glargine-sorella-1-study
#2
Satish Garg, Karin Wernicke-Panten, Maria Rojeski, Suzanne Pierre, Yvonne Kirchhein, Krystyna Jedynasty
BACKGROUND: SAR342434 is a biosimilar (follow-on) of insulin lispro-Humalog®. This study aimed to show similar efficacy, safety and immunogenicity of SAR342434 (SAR-Lis) versus insulin lispro-Humalog (Ly-Lis) in adult patients with type 1 diabetes (T1DM) treated with multiple daily injections while using basal insulin glargine (Lantus®; GLA100GLA-100). MATERIALS AND METHODS: SORELLA-1 was a randomized, open-label Phase 3 study (NCT02273180). Patients completing the 6-month main study continued on SAR-Lis or Ly-Lis, as randomized, for a 6-month safety extension...
July 19, 2017: Diabetes Technology & Therapeutics
https://www.readbyqxmd.com/read/28722271/beyond-glycemic-control-a-cross-over-double-blind-24-week-intervention-with-liraglutide-in-type-1-diabetes
#3
M-C Dubé, M D'Amours, S J Weisnagel
AIMS: To investigate the effects of 24 weeks of treatment with liraglutide added to basal/bolus insulin on anthropometric and metabolic parameters in overweight participants with type 1 diabetes. METHODS: In a double-blind cross-over fashion, 15 participants were randomly assigned (1:1) to receive placebo (saline solution) or liraglutide for 24 weeks including a one-month titration period from 0.6 mg to 1.2 mg to 1.8 mg, in addition to their insulin. The treatment was followed by a 1 month wash-out period...
July 18, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28722242/therapeutic-application-of-gpr119-ligands-in-metabolic-disorders
#4
REVIEW
Jin Won Yang, Hyo Seon Kim, Yong-Won Choi, Young-Mi Kim, Keon Wook Kang
GPR119 belongs to the G protein-coupled receptor family, and exhibits dual modes of action upon ligand-dependent activation: pancreatic secretion of insulin in a glucose-dependent manner, and intestinal secretion of incretins. Hence, GPR119 has emerged as a promising target for treating type 2 diabetes mellitus without causing hypoglycemia. However, despite continuous efforts by many major pharmaceutical companies, no synthetic GPR119 ligand has been approved as a new class of anti-diabetic agents thus far, nor has one passed beyond phase II clinical studies...
July 18, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28721686/rationale-for-initiation-and-titration-of-the-basal-insulin-glp-1ra-fixed-ratio-combination-products-ideglira-and-iglarlixi-for-the-management-of-type-2-diabetes
#5
REVIEW
Virginia Valentine, Jennifer Goldman, Jay H Shubrook
Type 2 diabetes (T2D) is a progressive disease affecting glucose regulation and a major cause of morbidity and mortality globally. Many patients are not escalated up the treatment ladder appropriately despite failing to achieve glycemic control, with barriers such as fear of hypoglycemia, weight gain, and treatment burden recognized as factors. Exogenous basal insulin is titrated to address control of fasting plasma glucose and may preserve residual β-cell function, thus promoting a greater endogenous prandial insulin response...
July 18, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28721220/severe-diabetic-ketoacidosis-complicated-by-hypocapnic-seizure
#6
A Majid, B J Wheeler
In clinical practice, seizures independent of hypoglycemia are observed in patients with type 1 diabetes mellitus (T1DM) more frequently than expected by chance, suggesting a link. However, seizures during management of diabetic ketoacidosis (DKA) have generally been considered a bad prognostic factor, and usually associated with well-known biochemical or neurological complications. We present the case of a 17-year-old girl with known T1DM managed for severe DKA complicated by hypocapnic seizure. We review the literature on this rare occurrence as well as outline other possible differentials to consider when faced with the alarming combination of DKA and seizure...
2017: Endocrinology, Diabetes & Metabolism Case Reports
https://www.readbyqxmd.com/read/28721081/insulin-glargine-300-u-ml-for-basal-insulin-therapy-in-type-1-and-type-2-diabetes-mellitus
#7
REVIEW
Ip Tim Lau, Ka Fai Lee, Wing Yee So, Kathryn Tan, Vincent Tok Fai Yeung
OBJECTIVE: To review published clinical studies on the efficacy and safety of new insulin glargine 300 units/mL (Gla-300), a new long-acting insulin analog, for the treatment of type 1 and type 2 diabetes mellitus (T1DM, T2DM). MATERIALS AND METHODS: Data sources comprised primary research articles on Gla-300, including pharmacodynamic, pharmacokinetic, and clinical studies. RESULTS: In pharmacodynamic and pharmacokinetic studies, Gla-300 showed a flatter time-action profile and longer duration of action than Gla-100...
2017: Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy
https://www.readbyqxmd.com/read/28721055/chitosan-oligosaccharide-improves-the-therapeutic-efficacy-of-sitagliptin-for-the-therapy-of-chinese-elderly-patients-with-type-2-diabetes-mellitus
#8
Lijie Zhao, Tingli Sun, Lina Wang
Sitagliptin improves glycemic control in type 2 diabetes mellitus (T2DM) patients but its side effects are undesirable. Chitosan oligosaccharide (COS) is expected to improve the therapeutic result as a natural product. A total of 200 elderly T2DM patients were evenly assigned into four groups: sitagliptin group (SG), receiving sitagliptin 100 mg/day; COS group (CG), receiving COS 100 mg/day; combination therapy of sitagliptin and COS group (SCG), receiving both sitagliptin and COS 100 mg/day; and placebo group (PG), receiving placebo 100 mg/day...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28719066/insights-into-optimal-basal-insulin-titration-in-type-2-diabetes-results-of-a-quantitative-survey
#9
Lori Berard, Mireille Bonnemaire, Marie Mical, Steve Edelman
AIMS: Basal insulin (BI) treatment initiation and dose titration in type 2 diabetes (T2DM) are often delayed. Such "clinical inertia" results in poor glycemic control and high risk of long-term complications. This survey aimed to determine healthcare professional (HCP) and patient attitudes to BI initiation and titration. METHODS: An online survey (July-August 2015) including HCPs and patients with T2DM in the USA, France and Germany. Patients were ≥18 years old and had been on BI for 6-36 months, or discontinued BI within the previous 12 months...
July 18, 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28717335/evaluation-of-therapeutic-effectiveness-of-prescribed-medications-in-patients-with-type-2-diabetes-mellitus-findings-from-a-tertiary-care-hospital-lahore-pakistan
#10
Bareera Rana, Allah Bukhsh, Tahir Mehmood Khan, Ammar Sarwar, Muhammad Ovais Omer, Shazia Qasim Jamshed
AIM: The present study was aimed to highlight the current prescribing pattern of oral hypoglycemia in type 2 diabetes mellitus and to evaluate the therapeutic effectiveness of these therapeutic categories in achieving target glycemic control. METHODS: This is a prospective, cross-sectional, observational study of 6 months' duration conducted in a tertiary care hospital of Lahore, Pakistan. RESULTS: The current research recruited 145 patients presented in diabetes management center of a tertiary care hospital in Lahore, Pakistan...
April 2017: Journal of Pharmacy & Bioallied Sciences
https://www.readbyqxmd.com/read/28715810/population-pharmacokinetics-of-diazoxide-in-children-with-hyperinsulinemic-hypoglycemia
#11
Rika Kizu, Kazuko Nishimura, Reiko Sato, Kenjiro Kosaki, Toshiaki Tanaka, Yusuke Tanigawara, Tomonobu Hasegawa
BACKGROUND: Diazoxide is the first-line treatment for pediatric hyperinsulinemic hypoglycemia (HI). This study aimed to elucidate the pharmacokinetics of diazoxide in children with HI. METHODS: We obtained 81 blood samples from 22 children with HI. Measured serum diazoxide concentrations were used for population pharmacokinetic analysis. Patient factors influencing pharmacokinetics were estimated using nonlinear mixed-effects model analysis. Relationships between drug exposure and adverse drug reactions were also investigated...
July 14, 2017: Hormone Research in Pædiatrics
https://www.readbyqxmd.com/read/28714741/the-efficacy-and-safety-of-adding-either-vildagliptin-or-glimepiride-to-ongoing-metformin-therapy-in-patients-with-type-2-diabetes-mellitus
#12
Gyuri Kim, Sewon Oh, Sang-Man Jin, Kyu Yeon Hur, Jae Hyeon Kim, Moon-Kyu Lee
OBJECTIVE: To compare the effects of either vildagliptin or glimepiride on glycemic variability, oxidative stress, and endothelial parameters in patients with type 2 diabetes mellitus (T2DM) inadequately controlled with metformin alone. METHODS: In this randomized, open-label, parallel study, 34 patients with T2DM being treated with metformin having an HbA1c of 7.0-10.0% were allocated into either the vildagliptin or glimepiride group. A mixed-meal tolerance test and 72-hour continuous glucose monitoring were conducted, and urinary 8-iso-prostaglandinF2α (PGF2α) and endothelial-dependent flow-mediated dilatation (FMD) were evaluated at baseline and after 12 weeks of treatment...
July 17, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28709629/what-happens-to-blood-glucose-concentrations-after-oral-treatment-for-neonatal-hypoglycemia
#13
Deborah L Harris, Greg D Gamble, Philip J Weston, Jane E Harding
OBJECTIVE: To determine the change in blood glucose concentration after oral treatment of infants with hypoglycemia in the first 48 hours after birth. STUDY DESIGN: We analyzed data from 227 infants with hypoglycemia (blood glucose <46.8 mg/dL, 2.6 mmol/L) born at a tertiary hospital who experienced 295 episodes of hypoglycemia. Blood glucose concentrations were measured (glucose oxidase) within 90 minutes after randomization to dextrose or placebo gel plus feeding with formula, expressed breast milk, or breast feeding...
July 11, 2017: Journal of Pediatrics
https://www.readbyqxmd.com/read/28708678/dysglycemia-glycemic-variability-and-outcome-after-cardiac-arrest-and-temperature-management-at-33%C3%A2-c-and-36%C3%A2-c
#14
Ola Borgquist, Matt P Wise, Niklas Nielsen, Nawaf Al-Subaie, Julius Cranshaw, Tobias Cronberg, Guy Glover, Christian Hassager, Jesper Kjaergaard, Michael Kuiper, Ondrej Smid, Andrew Walden, Hans Friberg
OBJECTIVES: Dysglycemia and glycemic variability are associated with poor outcomes in critically ill patients. Targeted temperature management alters blood glucose homeostasis. We investigated the association between blood glucose concentrations and glycemic variability and the neurologic outcomes of patients randomized to targeted temperature management at 33°C or 36°C after cardiac arrest. DESIGN: Post hoc analysis of the multicenter TTM-trial. Primary outcome of this analysis was neurologic outcome after 6 months, referred to as "Cerebral Performance Category...
August 2017: Critical Care Medicine
https://www.readbyqxmd.com/read/28704854/switching-from-premixed-insulin-to-basal-insulin-analogue-for-type-2-diabetes-and-role-of-dipeptidyl-peptidase-4-inhibitors
#15
Fernando Gómez-Peralta, Cristina Abreu, Gustavo Mora-Navarro, Pilar López-Morandeira, Esteban Pérez-Gutierrez, Blanca Cordero-García, Miguel Brito-Sanfiel
Introduction This study aimed to confirm the usefulness of basal insulin analogue plus oral antidiabetic drugs (OADs) for type 2 diabetes (T2D) patients inadequately controlled with premixed insulin with/without OADs and assess the role of dipeptidyl peptidase-4 (DPP-4) inhibitors within this regimen in clinical practice. Methods Spanish retrospective observational study that included 186 T2D patients with glycosylated hemoglobin (HbA1c) >7% (53 mmol/mol) despite premixed insulin with/without OADs who had been switched to basal insulin analogue plus OADs...
July 13, 2017: Experimental and Clinical Endocrinology & Diabetes
https://www.readbyqxmd.com/read/28702259/clinical-effects-cardiovascular-and-renal-outcomes-associated-with-rapid-acting-insulin-analogs-among-individuals-with-type-2-diabetes-a-nation-wide-observational-cohort-study
#16
Ann-Marie Svensson, Mervete Miftaraj, Stefan Franzén, Björn Eliasson
BACKGROUND: Rapid-acting insulin analogs (RAIs) have not been examined for long-term safety in randomized clinical trials. We performed a nationwide longitudinal cohort study among individuals with type 2 diabetes (T2DM) to address cardiovascular safety and mortality among users of lispro, aspart and glulisine insulins. METHODS: We used four national registers, following patients previously not treated with RAI but with continuous use of RAIs in 2005-2014 up to 6...
2017: Clinical Diabetes and Endocrinology
https://www.readbyqxmd.com/read/28701683/efficacy-and-safety-of-octreotide-for-the-treatment-of-congenital-hyperinsulinism-a-prospective-open-label-clinical-trial-and-an-observational-study-in-japan-using-a-nationwide-registry
#17
Yuki Hosokawa, Rie Kawakita, Susumu Yokoya, Tsutomu Ogata, Keiichi Ozono, Osamu Arisaka, Yukihiro Hasegawa, Satoshi Kusuda, Michiya Masue, Hironori Nishibori, Toshimi Sairenchi, Tohru Yorifuji
Octreotide, a long-acting somatostatin analog, has been used for treating hypoglycemia caused by congenital hyperinsulinism (CHI). However, octreotide has not been evaluated in clinical trials and has not been approved in any developed country. We aimed to test the efficacy and safety of octreotide for diazoxide-unresponsive CHI through a combination of a single-arm, open-label clinical trial (SCORCH study) and an observational study to collect data on the clinical course of patients treated off-label in Japan (SCORCH registry)...
July 11, 2017: Endocrine Journal
https://www.readbyqxmd.com/read/28698167/use-of-a-connected-glucose-meter-and-certified-diabetes-educator-coaching-to-decrease-the-likelihood-of-abnormal-blood-glucose-excursions-the-livongo-for-diabetes-program
#18
Janelle Downing, Jenna Bollyky, Jennifer Schneider
BACKGROUND: The Livongo for Diabetes Program offers members (1) a cellular technology-enabled, two-way messaging device that measures blood glucose (BG), centrally stores the glucose data, and delivers messages back to the individual in real time; (2) unlimited BG test strips; and (3) access to a diabetes coaching team for questions, goal setting, and automated support for abnormal glucose excursions. The program is sponsored by at-risk self-insured employers, health plans and provider organizations where it is free to members with diabetes or it is available directly to the person with diabetes where they cover the cost...
July 11, 2017: Journal of Medical Internet Research
https://www.readbyqxmd.com/read/28695415/the-real-life-effectiveness-and-care-patterns-of-diabetes-management-study-for-balkan-region-slovenia-croatia-serbia-bulgaria-a-multicenter-observational-cross-sectional-study
#19
Sanja Klobucar Majanovic, Andrej Janez, Ivaylo Lefterov, Sanja Tasic, Tatjana Cikac
INTRODUCTION: Recent large randomized controlled trials highlighted the clinical significance of hypoglycemic episodes in the treatment of diabetes. The present survey was conducted to provide information from real-life practice on the incidence of hypoglycemia in type 2 diabetic patients treated with sulfonylureas. METHODS: This multicenter, observational, cross-sectional study collected data on incidence of side effects of sulfonylurea-based therapy in type 2 diabetic patients in four countries of the Balkan region (Slovenia, Croatia, Serbia, Bulgaria) from October 2014 to June 2015...
July 10, 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28693122/postprandial-hyperinsulinemic-hypoglycemia-in-a-child-as-a-late-complication-of-esophageal-reconstruction
#20
Rade Vukovic, Tatjana Milenkovic, Maja Djordjevic, Katarina Mitrovic, Sladjana Todorovic, Adrijan Sarajlija, Khalid Hussain
BACKGROUND: Postprandial hyperinsulinemic hypoglycemia (PHH) is an increasingly recognized complication of gastric bypass surgery in obese adults, distinct from the "dumping syndrome". CASE PRESENTATION: Upon birth, primary repair of esophageal atresia was performed, and at the age of 14 months definite esophageal reconstruction was performed. At the age of 3 years, recurrent brief episodes of symptomatic hypoglycemia started. At the age of 5.7 years the girl was admitted to our clinic and investigations indicated hyperinsulinemic hypoglycemia...
June 24, 2017: Journal of Pediatric Endocrinology & Metabolism: JPEM
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