Percentage of participants with weight loss equal to or above 10% of their baseline (week 0) body weight was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 42 days. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. 6. Change from baseline (week 0) in waist circumference was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) 3 trial is a phase 3a comparative study that evaluated the efficacy, safety, and tolerability of once-weekly semaglutide … Albiglutide and cardiovascular outcomes in patients with type 2 diabetes and cardiovascular disease (Harmony Outcomes): a double-blind, randomised placebo-controlled trial. 2019 May;7(5):356-367. doi: 10.1016/S2213-8587(19)30066-X. For general information, Learn About Clinical Studies. Physical examination (cardiovascular system) results are presented for week -2 (baseline) and week 30. Efficacy and safety of once-weekly semaglutide versus exenatide ER in subjects with type 2 diabetes (SUSTAIN 3): a 56-week, open-label, randomized clinical trial. The aim of the trial is to investigate efficacy and safety of semaglutide once weekly versus … Hypoglycemia and diabetes: a report of a workgroup of the American Diabetes Association and the Endocrine Society. Change from baseline (week 0) in body mass index (BMI) was evaluated at week 30. Change from baseline (week 0) in eGFR was evaluated at week 30. Change from baseline (week 0) in FPG was evaluated at week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. All medications in compliance with current local label, Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice), Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol, Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. Results are based on the 'on-treatment without rescue medication' observation period. Fundoscopy results for both left and right eyes are presented for week 0 (baseline) and week 30. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Change from baseline (week 0) in mean post prandial increment (over all meals) in the SMPG, 7-point profile was evaluated at week 30. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Exenatide once weekly plus dapagliflozin once daily versus exenatide or dapagliflozin alone in patients with type 2 diabetes inadequately controlled with metformin monotherapy (DURATION-8): a 28 week, multicentre, double-blind, phase 3, randomised controlled trial. Also presented at the EASD meeting, the phase IIIb SUSTAIN 10 trial found that semaglutide was superior to the GLP-1 RA liraglutide (Victoza) for HbA1c and body weight … Results are based on the 'on-treatment without rescue medication' observation period. Contribution to the Literature: The SUSTAIN-6 trial showed that semaglutide is superior to placebo in improving glycemic control and reducing CV events in patients with DM2 and high CV … Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. GLP-1 agonists and blood pressure: a review of the evidence. The SUSTAIN 10 trial was the first Europe-based head-to-head trial to compare s.c. OW semaglutide vs s.c. OD liraglutide, and had relatively broad inclusion criteria in terms of the range of background medications and baseline characteristics. Results are based on the 'on-treatment without rescue medication' observation period. Glycemic efficacy, weight effects, and safety of once-weekly glucagon-like peptide-1 receptor agonists. The GLP-1 RA semaglutide (Ozempic)-- in combination with an SGLT-2 inhibitor -- was superior for decreasing HbA1c levels versus placebo in the phase IIIb SUSTAIN 9 trial, Novo Nordisk … Results are based on the 'on-treatment without rescue medication' observation period. Change from baseline (week 0) in HDL (measured in mmol/L and presented as ratio to baseline) was evaluated at week 30. Because of its progressive nature, many individuals receiving basal insulin require intensification of therapy to maintain optimal glycemic control and to reduce the risk of complications (1–5). Percentage of participants with HbA1c below 7.0% (53 mmol/mol) was evaluated at week 30. Items evaluating 6 aspects (items 3-8) of treatment satisfaction are summed to produce a total treatment satisfaction score; DTSQ status total scores range from 0-36, with higher scores indicating greater satisfaction; the perceived frequency of hyperglycemia/hypoglycemia items are scored separately, with lower scores indicating better perceived blood glucose control. ECG finding are presented as percentage of participants with normal, abnormal non-clinically significant (NCS) and abnormal clinically significant (CS) ECG values. Results are based on the 'on-treatment without rescue medication' observation period. Change from baseline (week 0) in pulse rate was evaluated at week 30. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Glycemic targets: standards of medical care in diabetes—2018. is generally well tolerated. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation, Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Efficacy and safety of once-weekly semaglutide versus once-daily sitagliptin as an add-on to metformin, thiazolidinediones, or both, in patients with type 2 diabetes (SUSTAIN 2): a 56-week, double-blind, phase 3a, randomised trial. (Adapted from New England Journal of Medicine [Marso SP, et al. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. Results are based on the 'on-treatment without rescue medication' observation period. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. Erratum in: Lancet Diabetes Endocrinol. Dapagliflozin and cardiovascular outcomes in type 2 diabetes. 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. Type 2 diabetes (T2D) is a complex disorder that requires individualized treatment strategies. Change from baseline (week 0) in body weight was evaluated at week 30. Lancet Diabetes Endocrinol. Results are presented as percentage of participants with normal, abnormal NCS and abnormal CS findings. Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03086330. Study record managers: refer to the Data Element Definitions if submitting registration or results information. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. Choosing to participate in a study is an important personal decision. Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. Why Should I Register and Submit Results? SUSTAIN-6 was a randomised, double-blind, placebo-controlled, parallel-group trial … SUSTAIN 7 was a 40-week, phase 3b, randomised, open-label, active-controlled, parallel group, four-armed trial done at 194 sites (hospitals, clinical institutions, or private practices) in 16 countries … Results are based on the on-treatment observation period, which started at the date of first dose of trial product and ended at the last date on trial product + 7 days. This questionnaire contains 36 items and measures the individual overall health related quality of life on 8 domains: 1) Physical functioning, 2) Role functioning, 3) Bodily pain, 4) General health, 5) Vitality, 6) Social functioning, 7) Role emotional and 8) Mental health. Percentage of participants with HbA1c below 7.0% (53 mmol/mol) without severe or BG confirmed symptomatic hypoglycaemia episodes and no weight gain from their baseline (week 0) body weight was evaluated at week 30. Higher PCS and MCS scores on a scale of 0-100 indicate a higher health status. Study Protocol and Statistical Analysis Plan. SUSTAIN 1-5: Trial Design SUSTAIN 3: (vs. QW GLP-I RA; OL) SUSTAIN 1: (Monotherapy; DB) Drug-naiVe N=388 30 weeks 1-2 OADs Met, TZD, SU N=813 56 weeks Semaglutide 1 mg Exenatide ER 2 mg ICH harmonised tripartite guideline: Guideline for Good Clinical Practice E6(R1). Results are based on the 'on-treatment without rescue medication' observation period. 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 … Each item is scored on a 7- point Likert scale ranging from 0 (very dissatisfied) to 6 (very satisfied). Change from baseline (week 0) in patient reported outcome (PRO) questionnaire, SF-36v2TM was evaluated at week 30. DOI:10.1016/ S2213-8587(19)30066-X, Recommend Lancet journals to your librarian. Change from baseline (week 0) in calcitonin was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period. BMI was calculated as 'body weight in kg/(height in meters) x (height in meters)'. Change from baseline (week 0) in thrombocytes was evaluated at week 30.
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