Efficacy and Safety of Semaglutide Once Weekly Versus Insulin Glargine Once Daily as add-on to Metformin With or Without Sulphonylurea in Insulin-naïve Subjects With Type 2 Diabetes
NCT ID: NCT02128932
Last Updated: 2019-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1089 participants
INTERVENTIONAL
2014-08-04
2015-09-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Semaglutide 0.5 mg/week
semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Semaglutide 1.0 mg/week
semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
Insulin glargine
insulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Interventions
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semaglutide
Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
insulin glargine
Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
Eligibility Criteria
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Inclusion Criteria
* Insulin-naïve subjects diagnosed with type 2 diabetes and on stable diabetes treatment with metformin or metformin and SU (metformin 1500 mg or higher or maximum tolerated dose and SU half of maximum allowed dose according to national label or higher) for at least 90 days before screening. Stable is defined as unchanged medication and unchanged dose
* HbA1c 7.0 - 10.0% (53 - 86 mmol/mol) both inclusive
* History of chronic or idiopathic acute pancreatitis
* Screening calcitonin value greater than or equal to 50 ng/L
* Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome 2
* Severe renal impairment defined as estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m\^2 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 Class IV
* Known proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
* Diagnosis of malignant neoplasm in the previous 5 years (except basal cell skin cancer or squamous cell skin cancer)
* Mental inability, unwillingness or language barrier precluding adequate understanding of or compliance with study procedures
Exclusion Criteria
* Any disorder which, in the opinion of the Investigator might jeopardise subject's safety or compliance with the protocol
18 Years
ALL
No
Sponsors
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Novo Nordisk A/S
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Registry (GCR, 1452)
Role: STUDY_DIRECTOR
Novo Nordisk A/S
Locations
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Novo Nordisk Investigational Site
Birmingham, Alabama, United States
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Ozark, Alabama, United States
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Tuscumbia, Alabama, United States
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Gilbert, Arizona, United States
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Phoenix, Arizona, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Elk Grove, California, United States
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Inglewood, California, United States
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La Mesa, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Pomona, California, United States
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Rialto, California, United States
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Rolling Hills Estates, California, United States
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Roseville, California, United States
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San Diego, California, United States
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San Mateo, California, United States
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Sherman Oaks, California, United States
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Spring Valley, California, United States
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Tustin, California, United States
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Walnut Creek, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Cooper City, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Marseille, , France
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Marseille Cédex 05, , France
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Nanterre, , France
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Narbonne, , France
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Nice, , France
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Strasbourg, , France
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Aguascalientes, , Mexico
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Amsterdam, , Netherlands
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Hoofddorp, , Netherlands
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Rotterdam, , Netherlands
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Skopje, , North Macedonia
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Tetovo, , North Macedonia
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Ponce, , Puerto Rico
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Piteşti, Argeş, Romania
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Oradea, Bihor County, Romania
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Cluj-Napoca, Cluj, Romania
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Bucharest, , Romania
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Iași, , Romania
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Košice, , Slovakia
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Moldava nad Bodvou, , Slovakia
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Piešťany, , Slovakia
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Púchov, , Slovakia
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Trenčín, , Slovakia
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Koper, , Slovenia
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Ljubljana, , Slovenia
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Novo Mesto, , Slovenia
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Johannesburg, Gauteng, South Africa
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Pretoria, Gauteng, South Africa
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Durban, KwaZulu-Natal, South Africa
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Cape Town, Western Cape, South Africa
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Basingstoke, , United Kingdom
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Bristol, , United Kingdom
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Harrogate, North Yorkshire, , United Kingdom
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Haxey, , United Kingdom
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Hull, , United Kingdom
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Ipswich, , United Kingdom
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Northwood, , United Kingdom
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Plymouth, , United Kingdom
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Salford, , United Kingdom
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Sidcup, , United Kingdom
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Soham, , United Kingdom
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Swansea, , United Kingdom
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Taunton, , United Kingdom
Countries
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References
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Rodbard HW, Bellary S, Hramiak I, Seino Y, Silver R, Damgaard LH, Nayak G, Zacho J, Aroda VR. GREATER COMBINED REDUCTIONS IN HbA1C >/=1.0% AND WEIGHT >/=5.0% WITH SEMAGLUTIDE VERSUS COMPARATORS IN TYPE 2 DIABETES. Endocr Pract. 2019 Jun;25(6):589-597. doi: 10.4158/EP-2018-0444. Epub 2019 Mar 13.
Aroda VR, Bain SC, Cariou B, Piletic M, Rose L, Axelsen M, Rowe E, DeVries JH. Efficacy and safety of once-weekly semaglutide versus once-daily insulin glargine as add-on to metformin (with or without sulfonylureas) in insulin-naive patients with type 2 diabetes (SUSTAIN 4): a randomised, open-label, parallel-group, multicentre, multinational, phase 3a trial. Lancet Diabetes Endocrinol. 2017 May;5(5):355-366. doi: 10.1016/S2213-8587(17)30085-2. Epub 2017 Mar 23.
Kapitza C, Dahl K, Jacobsen JB, Axelsen MB, Flint A. Effects of semaglutide on beta cell function and glycaemic control in participants with type 2 diabetes: a randomised, double-blind, placebo-controlled trial. Diabetologia. 2017 Aug;60(8):1390-1399. doi: 10.1007/s00125-017-4289-0. Epub 2017 May 19.
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. Diabetes Obes Metab. 2018 Sep;20(9):2291-2297. doi: 10.1111/dom.13331. Epub 2018 Jun 7.
Ahren B, Atkin SL, Charpentier G, Warren ML, Wilding JPH, Birch S, Holst AG, Leiter LA. 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. 2018 Sep;20(9):2210-2219. doi: 10.1111/dom.13353. Epub 2018 Jun 12.
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. Diabetes Obes Metab. 2018 Oct;20(10):2426-2434. doi: 10.1111/dom.13396. Epub 2018 Jul 9.
Aroda VR, Ahmann A, Cariou B, Chow F, Davies MJ, Jodar E, Mehta R, Woo V, Lingvay I. 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. Diabetes Metab. 2019 Oct;45(5):409-418. doi: 10.1016/j.diabet.2018.12.001. Epub 2019 Jan 4.
Husain M, Bain SC, Holst AG, Mark T, Rasmussen S, Lingvay I. Effects of semaglutide on risk of cardiovascular events across a continuum of cardiovascular risk: combined post hoc analysis of the SUSTAIN and PIONEER trials. Cardiovasc Diabetol. 2020 Sep 30;19(1):156. doi: 10.1186/s12933-020-01106-4.
Capehorn M, Ghani Y, Hindsberger C, Johansen P, Jodar E. Once-Weekly Semaglutide Reduces HbA1c and Body Weight in Patients with Type 2 Diabetes Regardless of Background Common OAD: a Subgroup Analysis from SUSTAIN 2-4 and 10. Diabetes Ther. 2020 May;11(5):1061-1075. doi: 10.1007/s13300-020-00796-z. Epub 2020 Mar 19.
Husain M, Bain SC, Jeppesen OK, Lingvay I, Sorrig R, Treppendahl MB, Vilsboll T. Semaglutide (SUSTAIN and PIONEER) reduces cardiovascular events in type 2 diabetes across varying cardiovascular risk. Diabetes Obes Metab. 2020 Mar;22(3):442-451. doi: 10.1111/dom.13955. Epub 2020 Feb 5.
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. J Clin Endocrinol Metab. 2020 Feb 1;105(2):dgz072. doi: 10.1210/clinem/dgz072.
Jendle J, Birkenfeld AL, Polonsky WH, Silver R, Uusinarkaus K, Hansen T, Hakan-Bloch J, Tadayon S, Davies MJ. Improved treatment satisfaction in patients with type 2 diabetes treated with once-weekly semaglutide in the SUSTAIN trials. Diabetes Obes Metab. 2019 Oct;21(10):2315-2326. doi: 10.1111/dom.13816. Epub 2019 Jul 12.
Related Links
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Other Identifiers
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2013-004392-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1146-0211
Identifier Type: OTHER
Identifier Source: secondary_id
NL47781.018.14
Identifier Type: REGISTRY
Identifier Source: secondary_id
NN9535-3625
Identifier Type: -
Identifier Source: org_study_id
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