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Efficacy and Safety of Semaglutide Once-weekly Versus Exenatide ER 2.0 mg Once-weekly as add-on to 1-2 Oral Antidiabetic Drugs (OADs) in Subjects With Type 2 Diabetes

NCT ID: NCT01885208

Last Updated: 2019-06-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

813 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-02

Study Completion Date

2015-07-13

Brief Summary

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This trial is conducted in Europe and North and South America. The aim of the trial is to investigate the efficacy and safety of semaglutide once-weekly versus exenatide ER (extended release) 2.0 mg once-weekly as add-on to 1-2 oral antidiabetic drugs (OADs) in subjects with type 2 diabetes.

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Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment

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COMPLETED PHASE3

Detailed Description

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Conditions

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Diabetes Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semaglutide 1.0 mg

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Exenatide ER 2.0 mg

Group Type ACTIVE_COMPARATOR

exenatide

Intervention Type DRUG

One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly

Interventions

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semaglutide

One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly

Intervention Type DRUG

exenatide

One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly

Intervention Type DRUG

Other Intervention Names

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Bydureon®

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Subjects diagnosed with type 2 diabetes and on stable diabetes treatment with 1-2 OADs (Metformin equal to or above 1500 mg or maximum tolerated dose and/or thiazolidinedione (TZD) and sulfonylureas (SUs) equal to or above half of maximum dose allowed according to national label) for at least 90 days prior to screening. Stable is defined as unchanged medication and unchanged dose - HbA1c 7.0 - 10.

Exclusion Criteria

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 week 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. An exception is short-term treatment (7 days or less in total) with insulin in connection with inter-current illness - History of chronic or idiopathic acute pancreatitis - Screening calcitonin value equal to or above 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 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 (NYHA) class IV
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Anniston, Alabama, United States

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Birmingham, Alabama, United States

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Pell City, Alabama, United States

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Glendale, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Burbank, California, United States

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Hawaiian Gardens, California, United States

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Lomita, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Northridge, California, United States

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Northridge, California, United States

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San Diego, California, United States

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Tustin, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Bradenton, Florida, United States

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Brandon, Florida, United States

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Coral Gables, Florida, United States

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Hialeah, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Plantation, Florida, United States

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Savannah, Georgia, United States

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Chicago, Illinois, United States

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Franklin, Indiana, United States

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Greenfield, Indiana, United States

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Muncie, Indiana, United States

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Louisville, Kentucky, United States

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Madisonville, Kentucky, United States

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Hyattsville, Maryland, United States

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Kalamazoo, Michigan, United States

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St Louis, Missouri, United States

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Las Vegas, Nevada, United States

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Mine Hill, New Jersey, United States

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Albuquerque, New Mexico, United States

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North Massapequa, New York, United States

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Syracuse, New York, United States

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West Seneca, New York, United States

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Greensboro, North Carolina, United States

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Hickory, North Carolina, United States

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Whiteville, North Carolina, United States

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Akron, Ohio, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Delaware, Ohio, United States

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Corvallis, Oregon, United States

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Portland, Oregon, United States

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Portland, Oregon, United States

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Lansdale, Pennsylvania, United States

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Norristown, Pennsylvania, United States

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Charleston, South Carolina, United States

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Mt. Pleasant, South Carolina, United States

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Murrells Inlet, South Carolina, United States

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Spartanburg, South Carolina, United States

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Chattanooga, Tennessee, United States

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Austin, Texas, United States

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Carrollton, Texas, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Irving, Texas, United States

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Katy, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Sugar Land, Texas, United States

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Alexandria, Virginia, United States

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Buenos Aires, , Argentina

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Buenos Aires, , Argentina

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CABA, , Argentina

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Lanús Este, , Argentina

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Mar del Plata, , Argentina

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Karlovac, , Croatia

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Osijek, , Croatia

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Slavonski Brod, , Croatia

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Virovitica, , Croatia

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Zagreb, , Croatia

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Helsinki, , Finland

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Helsinki, , Finland

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Kerava, , Finland

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Oulu, , Finland

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Turku, , Finland

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Châlons-en-Champagne, , France

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Corbeil-Essonnes, , France

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La Rochelle, , France

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Le Creusot, , France

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Nanterre, , France

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Roubaix, , France

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Strasbourg, , France

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Vénissieux, , France

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Dresden, , Germany

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Dresden, , Germany

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Duisburg, , Germany

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Hohenmölsen, , Germany

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Mannheim, , Germany

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Oldenburg, , Germany

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Rehlingen-Siersburg, , Germany

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Völklingen, , Germany

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Athens, , Greece

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Piraeus, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Bologna, , Italy

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Città di Castello, , Italy

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Milan, , Italy

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Palermo, , Italy

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Pavia, , Italy

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Roma, , Italy

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Siena, , Italy

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Amsterdam, , Netherlands

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Apeldoorn, , Netherlands

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Delft, , Netherlands

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Hoofddorp, , Netherlands

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Leeuwarden, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Venlo, , Netherlands

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Zoetermeer, , Netherlands

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Caguas, , Puerto Rico

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Manatí, , Puerto Rico

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Belgrade, , Serbia

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Belgrade, , Serbia

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Kragujevac, , Serbia

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Novi Sad, , Serbia

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Basel, , Switzerland

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Geneva, , Switzerland

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Lucerne, , Switzerland

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Sankt Gallen, , Switzerland

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Zollikerberg, , Switzerland

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Ayr, , United Kingdom

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Bath, , United Kingdom

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Bradford-on-Avon, , United Kingdom

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Haxey, , United Kingdom

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Headington, , United Kingdom

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Rotherham, , United Kingdom

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Countries

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United States Argentina Croatia Finland France Germany Greece Italy Netherlands Puerto Rico Serbia Switzerland United Kingdom

References

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Fonseca VA, Capehorn MS, Garg SK, Jodar Gimeno E, Hansen OH, Holst AG, Nayak G, Seufert J. Reductions in Insulin Resistance are Mediated Primarily via Weight Loss in Subjects With Type 2 Diabetes on Semaglutide. J Clin Endocrinol Metab. 2019 Sep 1;104(9):4078-4086. doi: 10.1210/jc.2018-02685.

Reference Type BACKGROUND
PMID: 30938762 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30865526 (View on PubMed)

Ahmann AJ, Capehorn M, Charpentier G, Dotta F, Henkel E, Lingvay I, Holst AG, Annett MP, Aroda VR. 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. Diabetes Care. 2018 Feb;41(2):258-266. doi: 10.2337/dc17-0417. Epub 2017 Dec 15.

Reference Type RESULT
PMID: 29246950 (View on PubMed)

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.

Reference Type RESULT
PMID: 29687620 (View on PubMed)

Petri KCC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Exposure-response analysis for evaluation of semaglutide dose levels in type 2 diabetes. Diabetes Obes Metab. 2018 Sep;20(9):2238-2245. doi: 10.1111/dom.13358. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29748996 (View on PubMed)

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.

Reference Type RESULT
PMID: 29766634 (View on PubMed)

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.

Reference Type RESULT
PMID: 29862621 (View on PubMed)

Carlsson Petri KC, Ingwersen SH, Flint A, Zacho J, Overgaard RV. Semaglutide s.c. Once-Weekly in Type 2 Diabetes: A Population Pharmacokinetic Analysis. Diabetes Ther. 2018 Aug;9(4):1533-1547. doi: 10.1007/s13300-018-0458-5. Epub 2018 Jun 15.

Reference Type RESULT
PMID: 29907893 (View on PubMed)

Malkin SJP, Russel-Szymczyk M, Liidemann G, Volke V, Hunt B. Once-Weekly Semaglutide Versus Once-Daily Liraglutide for the Treatment of Type 2 Diabetes: A Long-Term Cost-Effectiveness Analysis in Estonia. Diabetes Ther. 2019 Feb;10(1):159-176. doi: 10.1007/s13300-018-0542-x. Epub 2018 Dec 7.

Reference Type RESULT
PMID: 30535837 (View on PubMed)

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.

Reference Type RESULT
PMID: 30615985 (View on PubMed)

Overgaard RV, Lindberg SO, Thielke D. Impact on HbA1c and body weight of switching from other GLP-1 receptor agonists to semaglutide: A model-based approach. Diabetes Obes Metab. 2019 Jan;21(1):43-51. doi: 10.1111/dom.13479. Epub 2018 Aug 23.

Reference Type RESULT
PMID: 30047216 (View on PubMed)

Mosenzon O, Capehorn MS, De Remigis A, Rasmussen S, Weimers P, Rosenstock J. Impact of semaglutide on high-sensitivity C-reactive protein: exploratory patient-level analyses of SUSTAIN and PIONEER randomized clinical trials. Cardiovasc Diabetol. 2022 Sep 2;21(1):172. doi: 10.1186/s12933-022-01585-7.

Reference Type DERIVED
PMID: 36056351 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32998732 (View on PubMed)

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. J Clin Endocrinol Metab. 2020 Dec 1;105(12):e4593-604. doi: 10.1210/clinem/dgaa577.

Reference Type DERIVED
PMID: 32827435 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32193837 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31903692 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31769496 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31215727 (View on PubMed)

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2012-004826-92

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1135-8647

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-3624

Identifier Type: -

Identifier Source: org_study_id

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Study to Examine the Effect on Glucose Control and Safety/Tolerability of Exenatide Given Two Times a Day to Subjects With Type 2 Diabetes
NCT00111540 COMPLETED PHASE3
A Trial Comparing Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)
NCT03172494 COMPLETED PHASE3
A Trial Investigating the Efficacy and Safety of Insulin Degludec/Liraglutide Injection in Subjects With Type 2 Diabetes
NCT06559722 NOT_YET_RECRUITING PHASE3
Study of Effectiveness of Liraglutide Added to High Dose Insulin in Type II Diabetics
NCT01654120 COMPLETED PHASE4
A Study Comparing Exenatide With Basal Insulin in Achieving a Target HbA1c With Minimum Weight Gain in Type 2 Diabetes Patients
NCT00360334 COMPLETED PHASE3
Comparing Efficacy and Safety of CinnaGen-liraglutide Versus Victoza® in Patients With Type II Diabetes
NCT03421119 UNKNOWN PHASE3
Effects of Exenatide on Glycemic Control and Weight in Continuous Subcutaneous Insulin Infusion (CSII) Type 2 Treated Patients With Type 2 Diabetes
NCT01140893 UNKNOWN PHASE2/PHASE3
A Research Study to Compare a New Medicine Oral Semaglutide to a Dummy Medicine in Children and Teenagers With Type 2 Diabetes
NCT04596631 ACTIVE_NOT_RECRUITING PHASE3