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 Listing a study does not mean it has been evaluated by the U.S. Federal Government. After 40 weeks the reductions in HbA1c were 16.5 mmol/mol (1.5%) with semaglutide 0.5 mg and 12.1 mmol/mol (1.1%) … This review details the efficacy and safety profile of semaglutide in the SUSTAIN 1–5 and 7 trials, and its cardiovascular safety profile in the SUSTAIN 6 trial. doi: 10.1210/clinem/dgz072. The designs of SUSTAIN 1–5 and 7 have previously been published (16–20, 22, 23). In addition, the SUSTAIN 6 trial demonstrated … 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. Diabetes Obes Metab. 1d625979-6e7d-4a76-84a6-6a147d8d76ef Epub 2020 Feb 5. Warren M, Chaykin L, Trachtenbarg D, Nayak G, Wijayasinghe N, Cariou B. Semaglutide as a therapeutic option for elderly patients with type 2 diabetes: Pooled analysis of the SUSTAIN 1-5 trials. Estimated mean change from baseline in HbA1c at week 30. Please remove one or more studies before adding more. More participants in the semaglutide group than in the placebo group achieved weight reductions of 5% or more (1047 participants [86.4%] vs. 182 [31.5%]), 10% or more (838 [69.1… Rodbard HW, Lingvay I, Reed J, de la Rosa R, Rose L, Sugimoto D, Araki E, Chu PL, Wijayasinghe N, Norwood P. Semaglutide Added to Basal Insulin in Type 2 Diabetes (SUSTAIN 5): A Randomized, Controlled Trial. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. False Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. J Clin Endocrinol Metab. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Semaglutide (Novo Nordisk, Denmark) is a new glucagon‐like peptide‐1 (GLP‐1) analogue for the treatment of type 2 diabetes, with 94% amino acid sequence homology to native GLP‐1 and with a half‐life of approximately 1 week. 385 0 obj <>stream Mean estimates are adjusted according to observed baseline distribution. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2019 Jan 4. Review. Mean estimates are adjusted according to observed baseline distribution. Phase 3b trials include SUSTAIN 7, and SUSTAIN 8 and 9 (both ongoing). Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. 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 1.0 mg s.c. versus that of once-weekly exenatide ER 2.0 mg s.c. over 56 weeks in adults with type 2 diabetes who are inadequately controlled on oral antidiabetic drugs (OADs). c Major adverse CV events (MACE)=CV death, nonfatal MI, or nonfatal stroke. The peptide backbone of semaglu-tide is similar to that of liraglutide and, like liraglutide, has a 94% homology with native GLP-1. The doses were chosen to represent the most common (liraglutide 1.2 mg) 6 and the anticipated most common (semaglutide 1.0 mg) prescription patterns in Europe and, thereby, increase the clinical relevance of the results. Aims: SUSTAIN 10 compared the efficacy and safety of the anticipated most frequent semaglutide dose (1.0mg) with the current most frequently prescribed liraglutide dose in Europe (1.2mg), reflecting clinical practice. Diabetes Obes Metab. 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. Another phase 3 clinical trial of Eli Lilly’s tirzepatide in Type 2 diabetics has met its primary endpoint. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. 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. Read our, ClinicalTrials.gov Identifier: NCT02305381, Interventional Adobe InDesign 14.0 (Windows) Missing data was imputed using mixed model for repeated measurements. Mean estimates are adjusted according to observed baseline distribution. 2020-10-28T15:44:01Z 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4. xmp.did:2b485837-f05d-c746-9c70-3e3b23351ce4 endobj Ahrén B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. Choosing to participate in a study is an important personal decision. Semaglutide subcutaneous formulation proved efficacious across SUSTAIN trials; semaglutide sc 0.5 mg and 1 mg reduced HbA1c levels by 1.8% from baseline and 57–74% of cases experienced a reduction of HbA1c levels to less than 7% with 0.5 mg and 67–79% with 1 mg. 0 mg. We assessed the efficacy, safety, and tolerability of semaglutide monotherapy compared with placebo, in treatment-naive patients with type 2 diabetes who had insufficient glycaemic control with diet and exercise alone. 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 Dia… (Clinical Trial), Efficacy and Safety of Semaglutide Once-weekly Versus Placebo as add-on to Basal Insulin Alone or Basal Insulin in Combination With Metformin in Subjects With Type 2 Diabetes, Placebo Comparator: Semaglutide Placebo 0.5 mg/Week, Placebo Comparator: Semaglutide Placebo 1.0 mg/Week, 18 Years and older (Adult, Older Adult), Anaheim, California, United States, 92801, Los Angeles, California, United States, 90057-3550, Northridge, California, United States, 91325, Riverside, California, United States, 92506, Roseville, California, United States, 95661, San Ramon, California, United States, 94583, Van Nuys, California, United States, 91405, Walnut Creek, California, United States, 94598, Waterbury, Connecticut, United States, 06708, Fleming Island, Florida, United States, 32003, Jacksonville, Florida, United States, 32204, Port Charlotte, Florida, United States, 33952, Spring Hill, Florida, United States, 34609, Gillespie, Illinois, United States, 62033, Greenfield, Indiana, United States, 46140, Indianapolis, Indiana, United States, 46254, Council Bluffs, Iowa, United States, 51501, Overland Park, Kansas, United States, 66209, Lexington, Kentucky, United States, 40503, Metairie, Louisiana, United States, 70002, Rockville, Maryland, United States, 20852, Waltham, Massachusetts, United States, 02453, Ann Arbor, Michigan, United States, 48106, Kalamazoo, Michigan, United States, 49009, Jackson, Mississippi, United States, 39209, Teaneck, New Jersey, United States, 07666, Albuquerque, New Mexico, United States, 87102, West Seneca, New York, United States, 14224, Oklahoma City, Oklahoma, United States, 73162-4704, Levittown, Pennsylvania, United States, 19056-2404, Philadelphia, Pennsylvania, United States, 19114, Bristol, Tennessee, United States, 37620-7352, Chattanooga, Tennessee, United States, 37411, Kingsport, Tennessee, United States, 37660, Saint Ingbert-Oberwürzbach, Germany, 66386, Change in HbA1c (Glycosylated Haemoglobin) [ Time Frame: Week 0, week 30 ], Change in Body Weight [ Time Frame: Week 0, week 30 ], Change in Fasting Plasma Glucose (FPG) [ Time Frame: week 0, week 30 ], Change in Insulin Dose [ Time Frame: week 0, week 30 ], Change in Systolic and Diastolic Blood Pressure [ Time Frame: week 0, week 30 ], Patient Reported Outcomes, Diabetes Treatment Satisfaction Questionnaire (DTSQ) [ Time Frame: week 0, week 30 ], HbA1c Below 7.0% (53 mmol/Mol) American Diabetes Association (ADA) Target [ Time Frame: After 30 weeks treatment ], HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target [ Time Frame: After 30 weeks treatment ]. Estimated mean change from baseline in insulin dose at week 30 was measured in terms of ratio to baseline. 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. Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number): Why Should I Register and Submit Results? Diabetologia. Japan: Adequate contraceptive measures are abstinence (not having sex), diaphragm, condom (by the partner), intrauterine device, sponge, spermicide or oral contraceptives - Treatment with any glucose lowering agents other than stated in the inclusion criteria in a period of 90 days before screening. As add-on to the pre-trial background medication. Missing data was imputed using last observation carried forward. The trial design is shown in Fig. Cardiovasc Diabetol. Semaglutide-treated patients also experienced greater weight loss, at an average of 5.3 kg … Bagsværd, Denmark, 17 November 2020 - Novo Nordisk today announced headline results from the SUSTAIN FORTE trial, a phase 3b 40-week, efficacy and safety trial with once-weekly semaglutide … SUSTAIN 1–5 trials, showed that nausea/vomiting contributed only minimally to the superior weight loss with once-weekly semaglutide, a glucagon- like peptide-1 receptor agonist, versus mixed-class comparators. Estimated mean change from baseline in FPG at week 30. proof:pdf armed trial (semaglutide 0.5 mg and 1.0 mg once weekly, and volume-matched placebo), with the primary analysis performed on pooled semaglutide and placebo groups,32 whereas PIONEER 6 was a two-armed trial (oral semaglutide target dose 14 mg once daily and placebo).33 The primary outcome in both trials was the time to first occurrence of a three-component MACE (CV death, nonfatal myocar … Semaglutide is a new GLP-1 analog for the once-weekly treatment of T2D. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment, country and stratification variable (HbA1c level at screening [<= 8.0% or > 8.0%] crossed with use of metformin [yes or no]; 2 by 2 levels) as fixed factors and baseline value as covariate, all nested within visit. xmp.id:4a5a4b07-c2d0-6845-9660-18b2145b7672 Adobe PDF Library 15.0 application/pdf J Clin Endocrinol Metab. <>>> You have reached the maximum number of saved studies (100). Diabetes Obes Metab. The post-baseline responses are analysed using an ANCOVA model with treatment, country and stratification variables (HbA1c level at screening [<= 8.0% or > 8.0%] and use of metformin [yes or no]) as fixed factors and baseline value as covariate. What are the new findings? This post-hoc analysis assessed the effect of semaglutide on renal function by baseline eGFR in the SUSTAIN 6 trial. Novo Nordisk A/S, Denmark. 1. Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jódar E, Mehta R, Woo V, Lingvay I. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Total scores for treatment satisfaction range from 0-36. endobj endobj %PDF-1.4 %âãÏÓ Missing data was imputed using mixed model for repeated measurements. Information provided by (Responsible Party): This trial is conducted in Asia, Europe and the United States of America (USA). Semaglutide (0.5 mg or 1 mg) was compared to weekly injections of dulaglutide (0.75 mg or 1.5 mg) in the open-label SUSTAIN 7 trial. Epub 2018 Jun 12. For general information, Learn About Clinical Studies. The aim of this trial is to investigate efficacy and safety of semaglutide once-weekly versus placebo in drug-naïve subjects with type 2 diabetes. The DTSQs questionnaire was used to assess subjects' treatment satisfaction and 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. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Injected subcutaneously (s.c. under the skin) once-weekly. Diabetes Obes Metab. Missing data was imputed using mixed model for repeated measurements. Estimated mean change from baseline in systolic and diastolic blood pressure at week 30. Response options range from 6 (best case) to 0 (worst case). Weight loss (WL) is slightly greater in people who experience GI AEs than those who do not. For Japan: Male or female, age at least 20 years at the time of signing informed consent - Subjects diagnosed with T2DM (type 2 diabetes mellitus) and on stable diabetes treatment (plus/minus 20 percent change in total daily dose) with basal insulin (minimum of 0.25 IU/kg/day and/or 20 IU/day of: insulin glargine, insulin detemir, insulin degludec and/or NPH insulin) alone or in combination with metformin (minimum of 1500 mg/day or maximal tolerable dose) for 90 days prior to screening - HbA1c (glycosylated haemoglobin) 7.0 - 10.0 percent (53 - 86 mmol/mol) both inclusive Exclusion Criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method throughout the trial including the 5 weeks follow-up period (adequate contraceptive measures as required by local regulation or practice). 2021-03-09T04:25:03-08:00 Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Håkan-Bloch J, Tadayon S, Davies MJ. Diabetes Obes Metab. xmp.did:B2C59A163194E611BD009A7CB80B8EC7 / 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 … default 384 0 obj Diabetes Metab. Overall, mean eGFR decreased from baseline to week 104 across all treatment groups and subgroups, with the largest decreases in subjects with normal renal function or mild renal impairment ([Figure][1]). Doses were escalated every 4 weeks until the The GLP-1 drug has already reaped billions for Novo Nordisk, taking in $1.64 billion in 2019 and $1.5 billion in the first half of 2020. Additionally, the trial shows that most patients tolerate concomitant treatment well. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Mar 13. It also reduced the body weight by up to 6.5 kg from baseline. STEP 1 - a 68-week safety and efficacy trial of sc semaglutide 2.4mg versus placebo in 1,961 adults with obesity or overweight. b Results apply to Ozempic ® plus standard of care vs standard of care alone in SUSTAIN 6 trial. <> Semaglutide is a glucagon-like peptide 1 (GLP-1) analogue in development with a half-life of approximately 7 days. doi:bmjdrc-2020-001706 Results: Semaglutide dose-dependently reduced the level of HbA1c from baseline (8.1 ± 0.8%) to week 12 by up to -1.7%, and body weight by up to -4.8 kg (1.6 mg E, P < 0.001 vs. placebo). Mean estimates are adjusted according to observed baseline distribution. The Semaglutide Unabated Sustainability in Treatment of Type 2 Diabetes (SUSTAIN) clinical trial program for semaglutide comprises 6 pivotal global phase 3a trials (SUSTAIN 1 through 6) and 2 Japanese phase 3a trials. 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.
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