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Omarigliptin

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https://www.readbyqxmd.com/read/29110647/a-randomized-placebo-controlled-clinical-trial-evaluating-the-safety-and-efficacy-of-the-once-weekly-dpp-4-inhibitor-omarigliptin-in-patients-with-type-2-diabetes-mellitus-inadequately-controlled-by-glimepiride-and-metformin
#1
Seung-Hwan Lee, Ira Gantz, Elizabeth Round, Melanie Latham, Edward A O'Neill, Paulette Ceesay, Shailaja Suryawanshi, Keith D Kaufman, Samuel S Engel, Eseng Lai
BACKGROUND: Type 2 diabetes (T2D) is a progressive disease that often requires a patient to use multiple antihyperglycemic agents to achieve glycemic control with disease progression. Omarigliptin is a once-weekly dipeptidyl peptidase-4 inhibitor. The purpose of this trial was to assess the efficacy and safety of adding omarigliptin to the treatment regimen of patients with T2D inadequately controlled by dual therapy with metformin and glimepiride. METHODS: Patients with T2D and HbA1c ≥7...
November 6, 2017: BMC Endocrine Disorders
https://www.readbyqxmd.com/read/29079379/a-randomized-double-blind-trial-evaluating-the-efficacy-and-safety-of-monotherapy-with-the-once-weekly-dipeptidyl-peptidase-4-inhibitor-omarigliptin-in-people-with-type-2-diabetes
#2
Philip Home, R Ravi Shankar, Ira Gantz, Carol Iredale, Edward A O'Neill, Lokesh Jain, Annpey Pong, Shailaja Suryawanshi, Samuel S Engel, Keith D Kaufman, Eseng Lai
AIMS: To assess the efficacy and safety of once-weekly omarigliptin as monotherapy in people with type 2 diabetes mellitus (T2DM). METHODS: People with T2DM not on glucose-lowering medications, or who were washed-off monotherapy or low-dose dual therapy, were randomized double-blind to omarigliptin 25 mg (n=165) or matching omarigliptin placebo (n=164) for 24 weeks, followed by a 30-week period to assess continuing efficacy and safety longer-term of omarigliptin during which metformin was added to the placebo group and metformin placebo to the omarigliptin group...
October 24, 2017: Diabetes Research and Clinical Practice
https://www.readbyqxmd.com/read/28923291/use-of-prohibited-medication-a-potentially-overlooked-confounder-in-clinical-trials-omarigliptin-once-weekly-dpp-4-inhibitor-monotherapy-trial-in-18-to-45-year-olds
#3
Ira Gantz, Liubov Sokolova, Lokesh Jain, Carol Iredale, Edward A O'Neill, Ziwen Wei, Raymond Lam, Shailaja Suryawanshi, Keith D Kaufman, Samuel S Engel, Eseng Lai
PURPOSE: The objective of this clinical trial was to assess the efficacy and safety of omarigliptin monotherapy in young adult patients with type 2 diabetes mellitus (T2DM). Unexpected efficacy results in this trial led to a series of investigations that identified the use of prohibited medication by a substantial number of trial patients. METHODS: Patients with T2DM who were ≥18 to <45 years of age and either drug-naive or not on an antihyperglycemic agent for ≥12 weeks with inadequate glycemic control were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 102) or placebo once weekly (n = 101) for 24 weeks...
September 15, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28893244/a-randomized-placebo-controlled-study-of-the-cardiovascular-safety-of-the-once-weekly-dpp-4-inhibitor-omarigliptin-in-patients-with-type-2-diabetes-mellitus
#4
Ira Gantz, Menghui Chen, Shailaja Suryawanshi, Catherine Ntabadde, Sukrut Shah, Edward A O'Neill, Samuel S Engel, Keith D Kaufman, Eseng Lai
BACKGROUND: Omarigliptin is a once-weekly (q.w.) oral DPP-4 inhibitor that is approved for the treatment of patients with type 2 diabetes mellitus (T2DM) in Japan. To support approval of omarigliptin in the United States, the clinical development program included a cardiovascular (CV) safety study. Subsequently, a business decision was made not to submit a marketing application for omarigliptin in the United States, and the CV safety study was terminated. Herein we report an analysis of data from that early-terminated study...
September 11, 2017: Cardiovascular Diabetology
https://www.readbyqxmd.com/read/28883229/efficacy-and-patient-satisfaction-of-the-weekly-dpp-4-inhibitors-trelagliptin-and-omarigliptin-in-80-japanese-patients-with-type-2-diabetes
#5
Takahiro Tosaki, Hideki Kamiya, Yuka Yamamoto, Tatsuhito Himeno, Yoshiro Kato, Masaki Kondo, Yuichiro Yamada, Akemi Inagaki, Kaori Tsubonaka, Chie Oshiro, Takami Katayama, Tomoyo Hayasaki, Yuki Nakaya, Haruna Fujiyoshi, Jiro Nakamura
Objective We investigated the efficacy, safety, and patient satisfaction of once-weekly DPP-4 inhibitors (DPP-4Is). Methods Either of two once-weekly DPP-4Is, trelagliptin or omarigliptin, was administered alone or in combination with other antidiabetic drugs in 80 outpatients with type 2 diabetes mellitus for 3 months. The HbA1c, glycoalbumin (GA), body weight, and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) scores were evaluated. Results Patients switching from other daily DPP-4Is (n=29) showed no significant changes in the HbA1c or GA levels...
October 1, 2017: Internal Medicine
https://www.readbyqxmd.com/read/28829213/safety-evaluation-of-trelagliptin-in-the-treatment-of-japanese-type-2-diabetes-mellitus-patients
#6
REVIEW
Kohei Kaku
Trelagliptin is a novel, long-acting dipeptidyl peptidase-4 (DPP-4) inhibitor approved for the treatment of type 2 diabetes mellitus (T2DM) in japan. The safety and efficacy of trelagliptin has been evaluated in three published clinical trials to date: one phase II and two phase III studies. As trelagliptin only requires dosing once per week, this new agent has the potential to improve compliance and subsequently, glycaemic control, in patients with T2DM. Areas covered: This article reviews the available safety data for trelagliptin from published clinical trials, and evaluates the published safety profile relative to competitor once-daily and once-weekly DPP-4 inhibitors...
November 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28776371/asymmetric-formal-synthesis-of-the-long-acting-dpp-4-inhibitor-omarigliptin
#7
Feng Peng, Yonggang Chen, Cheng-Yi Chen, Peter G Dormer, Amude Kassim, Mark McLaughlin, Robert A Reamer, Edward C Sherer, Zhiguo J Song, Lushi Tan, Matthew T Tudge, Baoqiang Wan, John Y L Chung
A highly efficient asymmetric synthesis of the key tetrahydropyranol intermediate of DPP-4 inhibitor omarigliptin (1) is described. The successful development of a protecting-group- and precious-metal-free synthesis was achieved via the discovery of a practical asymmetric Henry reaction and the application of a one-pot nitro-Michael-lactolization-dehydration through-process. Other features of the synthesis include a highly efficient MsCl-mediated dehydration and a crystallization-induced dynamic resolution for exceptional ee and dr upgrade...
August 14, 2017: Journal of Organic Chemistry
https://www.readbyqxmd.com/read/28737467/once-weekly-oral-antidiabetic-agent-and-treatment-satisfaction
#8
Mitsuyoshi Takahara, Toshihiko Shiraiwa, Naoto Katakami, Taka-Aki Matsuoka, Iichiro Shimomura
No abstract text is available yet for this article.
August 16, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28665228/absorption-metabolism-and-excretion-of-14-c-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-humans
#9
Shiyao Xu, Dan Tatosian, Ian Mcintosh, Maria Caceres, Catherine Matthews, Koppara Samuel, Diana Selverian, Sanjeev Kumar, Eunkyung Kauh
1. Omarigliptin (MARIZEV®) is a once-weekly DPP-4 inhibitor approved in Japan for the treatment of type 2 diabetes. The objective of this study was to investigate the absorption, metabolism and excretion of omarigliptin in humans. 2. Six healthy subjects received a single oral dose of 25 mg (2.1 µCi) [(14)C]omarigliptin. Blood, plasma, urine and fecal samples were collected at various intervals for up to 20 days post-dose. Radioactivity levels in excreta and plasma/blood samples were determined by accelerator mass spectrometry (AMS)...
June 30, 2017: Xenobiotica; the Fate of Foreign Compounds in Biological Systems
https://www.readbyqxmd.com/read/28589493/a-randomized-placebo-controlled-trial-evaluating-the-safety-and-efficacy-of-adding-omarigliptin-to-antihyperglycemic-therapies-in-japanese-patients-with-type-2-diabetes-and-inadequate-glycemic-control
#10
Ira Gantz, Taro Okamoto, Yuka Ito, Asako Sato, Kotoba Okuyama, Edward A O'Neill, Samuel S Engel, Eseng Lai
INTRODUCTION: Daily dipeptidyl peptidase-4 (DPP-4) inhibitors are commonly used with other orally administered antihyperglycemic agents (AHA), as combination therapy, to treat Japanese patients with type 2 diabetes. When combination therapy is indicated, use of a once-weekly (q.w.) orally administered DPP-4 inhibitor might be an appropriate therapeutic option for some patients. METHODS: A 52-week trial was conducted to assess the safety and tolerability (primary objectives) and glycemic efficacy (secondary objectives) of the q...
August 2017: Diabetes Therapy: Research, Treatment and Education of Diabetes and related Disorders
https://www.readbyqxmd.com/read/28548024/a-randomized-double-blind-non-inferiority-trial-evaluating-the-efficacy-and-safety-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-or-glimepiride-in-patients-with-type-2-diabetes-inadequately-controlled-on-metformin-monotherapy
#11
Yehuda Handelsman, Brett Lauring, Ira Gantz, Carol Iredale, Edward A O'Neill, Ziwen Wei, Shailaja Suryawanshi, Keith D Kaufman, Samuel S Engel, Eseng Lai
OBJECTIVE: To evaluate the efficacy and safety of adding the once-weekly DPP-4 inhibitor omarigliptin or the sulfonylurea glimepiride to the treatment regimen of patients with type 2 diabetes (T2DM) and inadequate glycemic control on metformin monotherapy. METHODS: Patients with T2DM and HbA1c ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/day) were randomized to omarigliptin 25 mg once-weekly (n = 376) or glimepiride up to 6 mg once daily (n = 375) for 54 weeks...
June 28, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28547998/a-randomized-clinical-trial-evaluating-the-efficacy-and-safety-of-the-once-weekly-dipeptidyl-peptidase-4-inhibitor-omarigliptin-in-patients-with-type-2-diabetes-inadequately-controlled-on-metformin-monotherapy
#12
R Ravi Shankar, Silvio E Inzucchi, Victoria Scarabello, Ira Gantz, Keith D Kaufman, Eseng Lai, Paulette Ceesay, Shailaja Suryawanshi, Samuel S Engel
OBJECTIVE: To examine the efficacy and safety of the once-weekly (q.w.) dipeptidyl peptidase-4 inhibitor, omarigliptin, in patients with type 2 diabetes (T2DM) and inadequate glycemic control on metformin monotherapy. METHODS: In a randomized, double-blind trial, patients with T2DM on a stable dose of metformin monotherapy (≥1500 mg/day) with glycated hemoglobin (HbA1c) of 7.0-10.5% were randomized to omarigliptin 25 mg q.w. or matching placebo (n = 201 in both) for 24 weeks (primary timepoint) followed by an additional 80-week treatment period...
June 23, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28449368/a-randomized-placebo-and-sitagliptin-controlled-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dipeptidyl-peptidase-4-inhibitor-in-japanese-patients-with-type-2-diabetes
#13
Ira Gantz, Taro Okamoto, Yuka Ito, Kotoba Okuyama, Edward A O'Neill, Keith D Kaufman, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in Japanese patients with type 2 diabetes (T2D). METHODS: In a 24-week double-blind trial, 414 patients with T2D were randomized to omarigliptin 25 mg once weekly, sitagliptin 50 mg once daily or placebo. The double-blind period was followed by a 28-week open-label extension during which all patients received omarigliptin 25 mg once weekly. Efficacy endpoints were glycated haemoglobin (HbA1c), 2-hour postprandial glucose (PPG) and fasting plasma glucose (FPG) levels...
November 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/28449320/a-randomised-double-blind-trial-of-the-safety-and-efficacy-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-in-subjects-with-type-2-diabetes-and-renal-impairment
#14
Antonio Chacra, Ira Gantz, Geraldine Mendizabal, Lucila Durlach, Edward A O'Neill, Zachary Zimmer, Shailaja Suryawanshi, Samuel S Engel, Eseng Lai
AIMS: To assess the safety and efficacy of omarigliptin in subjects with type 2 diabetes mellitus (T2DM) and chronic renal impairment (RI). METHODS: Patients with T2DM with moderate RI (estimated glomerular filtration rate [eGFR] ≥30 to <60 mL/min/1.73 m(2) ) (N=114), severe RI (eGFR <30 mL/min/1.73 m(2) ) (N=55) or end-stage renal disease on dialysis (N=44), who were either not on an antihyperglycaemic agent therapy for at least 12 weeks at screening, washed-off of oral antihyperglycaemic agent monotherapy or low-dose dual combination therapy, or on insulin monotherapy, with baseline glycated haemoglobin (HbA1c) of 6...
April 27, 2017: International Journal of Clinical Practice
https://www.readbyqxmd.com/read/28448177/once-weekly-dipeptidyl-peptidase-4-inhibitors-for-type-2-diabetes-a-systematic-review-and-meta-analysis
#15
REVIEW
Dimitrios Stoimenis, Thomas Karagiannis, Anastasia Katsoula, Eleni Athanasiadou, Kyriakos Kazakos, Eleni Bekiari, David R Matthews, Apostolos Tsapas
OBJECTIVE: To assess the efficacy and safety of omarigliptin and trelagliptin, novel dipeptidyl peptidase-4 inhibitors administered once-weekly (DPP-4i QW). METHODS: We systematically searched for placebo- and active-controlled randomized trials in adults with type 2 diabetes mellitus. RESULTS: Fifteen primary studies with 5709 participants were included. DPP-4i QW were more effective than placebo in reducing hemoglobin A1c (HbA1c) (Weighted Mean Difference (WMD) -0...
June 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28317144/ultra-high-pressure-liquid-chromatography-tandem-mass-spectrometry-method-for-the-determination-of-omarigliptin-in-rat-plasma-and-its-application-to-a-pharmacokinetic-study-in-rats
#16
Meng-Fang Li, Xiao-Xia Hu, Ai-Qun Ma
Omarigliptin is a novel long-acting dipeptidyl peptidase-4 inhibitor used for the treatment of type 2 diabetes. In this work, a sensitive and selective ultra-high pressure liquid chromatography tandem mass spectrometry method was developed and validated for the determination of omarigliptin in rat plasma. Sample preparation was performed by protein precipitation with acetonitrile. Chromatographic separation of analytes was achieved on an RRHD Eclipse Plus C18 column (2.1 × 50 mm, 1.8 μm), using gradient mobile phase (0...
October 2017: Biomedical Chromatography: BMC
https://www.readbyqxmd.com/read/28260743/pharmacological-action-and-clinical-results-of-omarigliptin-marizev-%C3%A2-tablet-a-novel-dipeptidyl-peptidase-4-inhibitor-for-once-weekly-treatment-of-type-2-diabetes
#17
REVIEW
Yuka Ito, Masahiko Mori, Yuki Matsumoto, Taro Okamoto
No abstract text is available yet for this article.
2017: Nihon Yakurigaku Zasshi. Folia Pharmacologica Japonica
https://www.readbyqxmd.com/read/28093853/randomized-clinical-trial-comparing-the-efficacy-and-safety-of-treatment-with-the-once-weekly-dipeptidyl-peptidase-4-dpp-4-inhibitor-omarigliptin-or-the-once-daily-dpp-4-inhibitor-sitagliptin-in-patients-with-type-2-diabetes-inadequately-controlled-on-metformin
#18
MULTICENTER STUDY
Ronald Goldenberg, Ira Gantz, Paula J Andryuk, Edward A O'Neill, Keith D Kaufman, Eseng Lai, Yin Na Wang, Shailaja Suryawanshi, Samuel S Engel
AIM: To compare the efficacy and safety of the once-weekly oral dipeptidyl peptidase-4 (DPP-4) inhibitor omarigliptin or once-daily DPP-4 inhibitor sitagliptin in patients with type 2 diabetes (T2DM) and inadequate glycaemic control on metformin. MATERIALS AND METHODS: Patients with T2DM with a glycated haemoglobin (HbA1c) concentration ≥6.5% to ≤9.0% while on a stable dose of metformin (≥1500 mg/d) were randomized in a double-blind manner to receive omarigliptin 25 mg once weekly (n = 322) or sitagliptin 100 mg once daily (n = 320)...
March 2017: Diabetes, Obesity & Metabolism
https://www.readbyqxmd.com/read/27627194/a-thorough-qtc-study-confirms-early-pharmacokinetics-qtc-modeling-a-supratherapeutic-dose-of-omarigliptin-a-once-weekly-dpp-4-inhibitor-does-not-prolong-the-qtc-interval
#19
Daniel A Tatosian, Nadia Cardillo Marricco, Xiaoli Shirley Glasgow, Bruce DeGroot, Katherine Dunnington, Laura George, Isaias Noel Gendrano, Amy O Johnson-Levonas, Dennis Swearingen, Eunkyung Kauh
Omarigliptin is a dipeptidyl peptidase-4 inhibitor being developed as a once-weekly treatment for type 2 diabetes. This double-blind, double-dummy, randomized, 3-period balanced crossover study definitively evaluated the effects of a supratherapeutic omarigliptin dose on QTc interval. Population-specific correction of QT interval (QTcP) was used for the primary analysis. Healthy subjects (n = 60) were enrolled and received treatments separated by a ≥4-week washout: (1) single-dose 25 mg omarigliptin (day 1), single-dose 175 mg omarigliptin (day 2); (2) placebo (day 1) followed by single-dose 400 mg moxifloxacin (day 2); (3) placebo (days 1 and 2)...
September 2016: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/27627193/effects-of-age-sex-and-obesity-on-the-single-dose-pharmacokinetics-of-omarigliptin-in-healthy-subjects
#20
Carol Addy, Daniel A Tatosian, Xiaoli S Glasgow, Isaias Noel Gendrano Iii, Christine McCrary Sisk, Eunkyung A Kauh, S Aubrey Stoch, John A Wagner
Omarigliptin is being developed as a potent, once-weekly, oral dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. This double-blind, randomized, placebo-controlled study evaluated the effects of age, sex, and obesity on the pharmacokinetics of omarigliptin in healthy subjects. A single oral dose of omarigliptin 10 mg (n = 6/panel) or placebo (n = 2/panel) was administered in the fasted state to elderly nonobese men and women, young obese (30 ≤ body mass index [BMI] ≤ 35 kg/m(2) ) men and women, and young nonobese women of nonchildbearing potential...
September 2016: Clinical Pharmacology in Drug Development
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