Intensive blood-glucose control with sulphonylureas or insulin compared with conventional treatment and risk of complications in patients with type 2 diabetes (UKPDS 33). Read our, ClinicalTrials.gov Identifier: NCT01930188, Interventional Please remove one or more studies before adding more. Sustain, part 1 4m 31s. Sustain, part 1. Diabetes Metab. Objective: To demonstrate the superiority of semaglutide vs placebo on glycemic control as an add-on to basal insulin in patients with T2D. You started this assessment previously and didn't complete it. Epub 2018 Jul 9. Diabetes Ther. Regulatory guidance specifies the need to establish the cardiovascular safety of new therapies for type 2 diabetes in order to rule out excess cardiovascular risk.5 The preapproval Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diab… Efficacy and safety of once-weekly GLP-1 receptor agonist albiglutide (HARMONY 2): 52 week primary endpoint results from a randomised, placebo-controlled trial in patients with type 2 diabetes mellitus inadequately controlled with diet and exercise. This trial assesses the efficacy and safety of semaglutide, a GLP-1RA, as an add-on to basal insulin. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Epub 2017 Apr 3. An overview of once-weekly glucagon-like peptide-1 receptor agonists--available efficacy and safety data and perspectives for the future. ePoster #767 presented 12 Sep 2016 at European Association for the Study of Diabetes - 52nd Annual Meeting. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Marijuana is a commonly abused illicit drug that is typically first used during adolescence. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. In the United States there are roughly 2.5 million new marijuana users annually and about 75% of these new users are age 18 or younger (Substance Abuse and Mental Health Services Administration, 2004).Over 40 percent of high school seniors have used marijuana at least once and … Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Inclusion Criteria: - Japan: Age minimum 20 years - Subjects diagnosed with type 2 diabetes and on stable treatment in a period of 90 days prior to screening with either metformin above or equal to 1500 mg (or maximum tolerated dose), pioglitazone above or equal to 30 mg (or maximum tolerated dose), rosiglitazone above or equal to 4 mg (or maximum tolerated dose) or a combination of either metformin/pioglitazone or metformin/rosiglitazone (doses as for individual therapies). 49mins Ram Janmabhoomi trust purchases 7,285-sq.ft adjoining land for ₹1 crore 52mins PM Modi to address conference of top military leadership on … Endocr Pract. GLP-1 receptors exist in the parietal cortex, hypothalamus and medulla of human brains and the GLP-1 analogue liraglutide alters brain activity related to highly desirable food cues in individuals with diabetes: a crossover, randomised, placebo-controlled trial. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Methods: We did a randomised, open-label, non-inferiority, parallel-group, multicentre, multinational, phase 3a trial (SUSTAIN 4) at 196 sites in 14 countries. Diabetes Metab. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Fonseca VA, Capehorn MS, Garg SK, Jódar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. The full text of this issue is available as a PDF document from the Toolkit section on this page. Applicants must be US citizens or permanent residents. Insights from the SUSTAIN 1-7 trials. The trial drug will be added on to the subject's stable pre-trial medication. GREATER COMBINED REDUCTIONS IN HbA(1C) ≥1.0% AND WEIGHT ≥5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. 8. pii: dgz072. The results were reported in July 2015. You have reached the maximum number of saved studies (100). Higher scores indicate higher satisfaction. Husain M, Bain SC, Jeppesen OK, Lingvay I, Sørrig R, Treppendahl MB, Vilsbøll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. The Regulation harmonises the assessment and supervision processes for clinical trials throughout the EU, via a Clinical Trials Information System (CTIS). Semaglutide and cardiovascular outcomes in patients with type 2 diabetes. Liraglutide versus glimepiride monotherapy for type 2 diabetes (LEAD-3 Mono): a randomised, 52-week, phase III, double-blind, parallel-treatment trial. The other trials were: SUSTAIN-1: A 30-week efficacy and safety trial of semaglutide vs placebo in 388 drug-naive people with type 2 diabetes. 0 mg once weekly or canagliflozin 300 mg once daily (these doses were the final doses in SUSTAIN 8 after dose escalation). Diabetes Obes Metab. A plethora of GLP-1 agonists: decisions about what to use and when. Independent glucose and weight-reducing effects of liraglutide in a real-world population of type 2 diabetic outpatients. The SUSTAIN 6 trial demonstrated that once-weekly semaglutide (0.5 and 1.0 mg) significantly reduced major adverse cardiovascular (CV) events (MACE) vs placebo in subjects with type 2 diabetes (T2D) and high CV risk. Epub 2018 Jun 12. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. 1.0 Introduction. Information provided by (Responsible Party): This trial is conducted in Africa, Asia, Europe and South America. Mean baseline HbA, To read this article in full you will need to make a payment. doi: 10.1210/clinem/dgaa577. Lingvay I, Capehorn MS, Catarig AM, Johansen P, Lawson J, Sandberg A, Shaw R, Paine A. Efficacy of Once-Weekly Semaglutide vs Empagliflozin Added to Metformin in Type 2 Diabetes: Patient-Level Meta-analysis. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. Start My Free Month. Quality of life in relation to overweight and body fat distribution. Course Overview; Transcript; View … Similar results were found in SUSTAIN-6 (Trial to Evaluate Cardiovascular and Other Long-term Outcomes With Semaglutide in Subjects With Type 2 Diabetes) with 0.5 and 1.0 mg doses of semaglutide; heart rate increased by 2.0 and 2.5 bpm, respectively, with robust reductions in A1C at study end (0.7 and 1.0%, respectively), systolic blood pressure (1.3 and 2.6 mmHg, respectively), and weight … Ahrén B, Comas LM, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Patient perspectives on once-weekly medications for diabetes. Standards of medical care in diabetes–2014. Now What? Interplay of the environmental, economic, and social aspects of sustainable development. Information supplied with products at the point of sale may be a potentially efficient delivery point for such a countermeasure. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. See more. Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of semaglutide or sitagliptin. Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jódar E. Once-Weekly Semaglutide Reduces HbA(1c) and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01930188. Semaglutide induces weight loss in subjects with type 2 diabetes regardless of baseline BMI or gastrointestinal adverse events in the SUSTAIN 1 to 5 trials. J Clin Endocrinol Metab. Semaglutide: SUSTAIN-6. Once we have gone through the stress of getting an important problem off our chest, it is easy to want to rush and end the conversation, but every important conversation must happen more than once. The trial drug will be added on to the subject's stable pre-trial medication. The SUSTAIN program provides 50% support (including benefits) for up to 2 awarded scholars per year. Sustain definition, to support, hold, or bear up from below; bear the weight of, as a structure. 842 n engl j med 381;9 nejm.orgAugust 29, 2019 The new england journal of medicine C ardiovascular disease is the pri-mary cause of death in patients with type 2 diabetes,1 … You can pick up where you left off, or start over. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. The effects of gender, age and baseline CV risk on outcomes are important considerations for further study. Type 2 diabetes in adults: management (NG28). 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Its origin can be traced back to ideas of scientific management pioneered by Frederick Taylor in the early 1900s (2,3). Background With long-standing and widespread high rates of errors in child restraint use, there is a need to identify effective methods to address this problem. Change in fasting plasma glucose from baseline to week 56. Diabetes Obes Metab. 2019 Apr 2. pii: jc.2018-02685. DeVries JH, Desouza C, Bellary S, Unger J, Hansen OKH, Zacho J, Woo V. Achieving glycaemic control without weight gain, hypoglycaemia, or gastrointestinal adverse events in type 2 diabetes in the SUSTAIN clinical trial programme. The key CV outcome results are summarized in Table 1. Figure 1.1. Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. The arcuate nucleus mediates GLP-1 receptor agonist liraglutide-dependent weight loss. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Efficacy and safety of dulaglutide monotherapy versus metformin in type 2 diabetes in a randomized controlled trial (AWARD-3). The Lancet Regional Health – Western Pacific, Advancing women in science, medicine and global health, Correction to Lancet Diabetes Endocrinol 2016; published online April 12. http://dx.doi.org/10.1016/S2213-8587(16)00036-X, Day-and-night glycaemic control with closed-loop insulin delivery versus conventional insulin pump therapy in free-living adults with well controlled type 1 diabetes: an open-label, randomised, crossover study, Access any 5 articles from the Lancet Family of journals, https://doi.org/10.1016/S2213-8587(17)30013-X, Efficacy and safety of once-weekly semaglutide monotherapy versus placebo in patients with type 2 diabetes (SUSTAIN 1): a double-blind, randomised, placebo-controlled, parallel-group, multinational, multicentre phase 3a trial, Semaglutide: a promising new glucagon-like peptide-1 receptor agonist, Semaglutide, lipid-lowering drugs, and NAFLD, Semaglutide, lipid-lowering drugs, and NAFLD – Author's reply, Recommend Lancet journals to your librarian, American Association of Clinical Endocrinologists, National Institute for Clinical Excellence, UK Prospective Diabetes Study (UKPDS) Group. See more. Oral Presentation 12 Jun 2016 at American Diabetes Association - 76th Annual Scientific Sessions. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. This questionnaire contained 8 components and evaluates the diabetes treatment (including insulin, tablets and/or diet) in terms of convenience, flexibility and general feelings towards the treatment. Epub 2019 Jul 12. Epub 2020 Feb 5. such as nausea. Diabetes Obes Metab. 2018 Sep;34(9):1595-1603. doi: 10.1080/03007995.2018.1476332. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. Relationship between weight change and glycaemic control in patients with type 2 diabetes receiving once-weekly dulaglutide treatment. The impact of weight gain on motivation, compliance, and metabolic control in patients with type 2 diabetes mellitus. Combating the dual burden: therapeutic targeting of common pathways in obesity and type 2 diabetes. The ‘Trial to Evaluate Cardiovascular and Other Long-term Outcomes with Semaglutide in Subjects with Type 2 Diabetes’ (SUSTAIN-6) was the next CVOT published in 2016.19 Participants were those with T2D who were 50 years of age and older with pre-existing cardiovascular disease, chronic heart failure or chronic kidney disease (stage 3 or higher), or 60 years … Eichmann in Jerusalem: A Report on the Banality of Evil is a 1963 book by political theorist Hannah Arendt.Arendt, a Jew who fled Germany during Adolf Hitler's rise to power, reported on Adolf Eichmann's trial for The New Yorker.A revised and enlarged edition was published in 1964. 2020 Feb 1;105(2). Reductions in insulin resistance are mediated primarily via weight loss in subjects with type 2 diabetes on semaglutide. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Talk with your doctor and family members or friends about deciding to join a study. Using electronic questionnaires, we aimed to gain a deeper understanding of this research priority. Subjects who achieved HbA1c ≤6.5% (48 mmol/mol) American Association of Clinical Endocrinologists (AACE) target (yes/no) after week 56 weeks of treatment. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4. An exception is short-term treatment (below or equal to 7 days in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value above or equal to 50 ng/L (pg/mL) - Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN 2) - Impaired renal function defined as estimated glomerular filtration rate (eGFR) below 60 ml/min/1.73 m2 per modification of diet in renal disease (MDRD) formula (4 variable version) - Acute coronary or cerebrovascular event within 90 days before randomisation - Heart failure, New York Heart Association (NYHA) class IV. Now what? 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Obesity and cardiovascular disease: pathophysiology, evaluation, and effect of weight loss: an update of the 1997 American Heart Association Scientific Statement on Obesity and Heart Disease from the Obesity Committee of the Council on Nutrition, Physical Activity, and Metabolism. J Clin Endocrinol Metab. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Credit: Mark Fedkin. Discovery of the once-weekly glucagon-like peptide-1 (GLP-1) analogue semaglutide. In both the CVOTs, trial completion rate was high (SUSTAIN 6: 97.6%; PIONEER 6: 99.7%) with vital status at end-of-trial known for 99.6% of patients in SUSTAIN 6 and 100% in PIONEER 6. The way clinical trials are conducted in the European Union (EU) will undergo a major change when the Clinical Trial Regulation (Regulation (EU) No 536/2014) comes into application. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.5 % (53 - 91 mmol/mol) (both inclusive) Exclusion Criteria: - Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local law or practice) - Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subject's safety or compliance with the protocol - Treatment with glucose lowering agent(s) other than stated in the inclusion criteria in a period of 90 days before screening. 2020 Dec 1;105(12). GLP-1 receptor activated insulin secretion from pancreatic beta-cells: mechanism and glucose dependence. Change in body weight from baseline to week 56. Resume Start Over. A phase 2, randomized, dose-finding study of the novel once-weekly human GLP-1 analog, semaglutide, compared with placebo and open-label liraglutide in patients with type 2 diabetes. For subcutaneous injection (s.c., under the skin) once weekly. Combining the distinct modes of action of these two drug classes has beneficial effects on glucose and weight outcomes. Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin. DeSouza C, Cariou B, Garg S, Lausvig N, Navarria A, Fonseca V. Efficacy and Safety of Semaglutide for Type 2 Diabetes by Race and Ethnicity: A Post Hoc Analysis of the SUSTAIN Trials. Ahrén B, Masmiquel L, Kumar H, Sargin M, Derving Karsbøl J, Jacobsen SH, Chow F. Efficacy and Safety of Once-weekly Semaglutide vs Sitagliptin as add-on to Metformin and/or Thiazolidinediones After 56 Weeks in Subjects With Type 2 Diabetes (SUSTAIN 2). Keyboard Shortcuts ; Preview This Course. The other 50% must be matched by the department, and the total effort devoted to research must be 75% or greater. Sharma R, Wilkinson L, Vrazic H, Popoff E, Lopes S, Kanters S, Druyts E. Comparative efficacy of once-weekly semaglutide and SGLT-2 inhibitors in type 2 diabetic patients inadequately controlled with metformin monotherapy: a systematic literature review and network meta-analysis. Lancet Diabetes Endocrinol. Skills covered in this course Business Communication. This trial is conducted in Asia, Europe and North America. Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. American Association of Clinical Endocrinologists medical guidelines for clinical practice for the management of diabetes mellitus. Comparative efficacy, safety, and cardiovascular outcomes with once-weekly subcutaneous semaglutide in the treatment of type 2 diabetes: Insights from the SUSTAIN 1-7 trials. The result presented is the 'Treatment Satisfaction' summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Epub 2019 Mar 13. Diabetes Metab. Diabetes Obes Metab. Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Epub 2020 Mar 19. Context: Combination therapy with insulin and glucagon-like peptide-1 receptor agonists (GLP-1RAs) is important for treating type 2 diabetes (T2D). Sustain, part 2 3m 14s. Efficacy and safety comparison of liraglutide, glimepiride, and placebo, all in combination with metformin, in type 2 diabetes: the LEAD (liraglutide effect and action in diabetes)-2 study. Choosing to participate in a study is an important personal decision. The DTSQs questionnaire was used to assess subjects' treatment satisfaction. Adopted from the University of Michigan Sustainability Assessment [Rodriguez et al., 2002] Dimensions of Sustainability. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Response options range from 6 (best case) to 0 (worst case). doi: 10.1210/jc.2018-02685. Sustain definition, to support, hold, or bear up from below; bear the weight of, as a structure. Donnanr et al Open 20199e022577 doi101136bmjopen2018022577 1 Open access Comparative safety of the sodium glucose co-transporter 2 (SGLT2) inhibitors: a systematic review and meta-analysis Jennifer R Donnan,1 Catherine A Grandy,1 Eugene Chibrikov,1 Carlo A Marra,1,2 Kris Aubrey-Bassler,3 Karissa Johnston,1 Michelle Swab,3 Jenna Hache,1 Daniel Curnew,1 Hai Nguyen,1 John-Michael … 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. doi: 10.1210/clinem/dgz072. Tablets for oral administration once daily. Diabetes Ther. Measuring beliefs about taking hypoglycaemic medication among people with Type 2 diabetes.  (Clinical Trial), Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin and/or TZD in Subjects With Type 2 Diabetes (SUSTAIN™ 2 - vs. DPP-4 Inhibitor), Experimental: Semaglutide 0.5 mg + sitagliptin placebo, Experimental: Semaglutide 1.0 mg + sitagliptin placebo, Active Comparator: Sitagliptin 100 mg + semaglutide placebo 1.0 mg, Active Comparator: Sitagliptin 100 mg + semaglutide placebo 0.5 mg, 18 Years and older   (Adult, Older Adult), Nizhniy Novgorod, Russian Federation, 603011, Saint-Petersburg, Russian Federation, 197762, East London, Eastern Cape, South Africa, 5201, Bloemfontein, Free State, South Africa, 9301, Johannesburg, Gauteng, South Africa, 2001, Durban, KwaZulu-Natal, South Africa, 4001, Durban, KwaZulu-Natal, South Africa, 4092, Change in HbA1c (Glycosylated Haemoglobin) From Baseline [ Time Frame: Week 0, week 56 ], Change in Body Weight From Baseline [ Time Frame: Week 0, week 56 ], Change in Fasting Plasma Glucose (FPG) From Baseline [ Time Frame: Week 0, week 56 ], Change in Systolic and Diastolic Blood Pressure From Baseline [ Time Frame: Week 0, week 56 ], Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline [ Time Frame: Week 0, week 56 ], Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no) [ Time Frame: After 56 weeks treatment ]. SUSTAIN 9 is the second clinical trial to show that the concomitant use of GLP-1 receptor agonists and SGLT-2 inhibitors is effective and generally well tolerated in patients with type 2 diabetes. In this video, learn the steps of maintaining and expanding your meaningful conversations. 2020 Jan 1;105(1):. Curr Med Res Opin. Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. part 1 ... MS Word, PDF, Google Doc, or Evernote. Subjects were grouped according to gender, age (50–65 … Epub 2018 May 29. Currently, few researchers think about the carbon footprint of their trial. Sensitivity analysis including only the most intensive intervention arms from multi-arm trials found a mean difference of −1.69 kg (−2.47 to −0.92 kg; I 2 =40%) compared with controls. Pancreatic GLP-1 receptor activation is sufficient for incretin control of glucose metabolism in mice. Efficacy and safety of exenatide once weekly versus metformin, pioglitazone, and sitagliptin used as monotherapy in drug-naive patients with type 2 diabetes (DURATION-4): a 26-week double-blind study. © 2017 Elsevier Ltd. All rights reserved. Epub 2018 Jun 15. Will follow a fixed dose escalation regimen.