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Efficacy and Safety of Oral Semaglutide Versus Empagliflozin in Subjects With Type 2 Diabetes Mellitus

NCT ID: NCT02863328

Last Updated: 2022-07-20

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

822 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-08-10

Study Completion Date

2018-03-08

Brief Summary

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This trial is conducted globally. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide versus Empagliflozin in Subjects with Type 2 Diabetes Mellitus.

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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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14 mg oral semaglutide

Group Type EXPERIMENTAL

semaglutide

Intervention Type DRUG

Oral administration once-daily.

25 mg empagliflozin

Group Type ACTIVE_COMPARATOR

empagliflozin

Intervention Type DRUG

Oral administration once-daily.

Interventions

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semaglutide

Oral administration once-daily.

Intervention Type DRUG

empagliflozin

Oral administration once-daily.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Male or female, age above or equal to 18 years at the time of signing informed consent
* Diagnosed with type 2 diabetes mellitus at least 90 days prior to day of screening
* HbA1c (glycosylated haemoglobin) of 7.0-10.5 % (53-91 mmol/mol) (both inclusive)
* Stable daily dose of metformin (at least 1500 mg or maximum tolerated dose as documented in the subject medical record) at least 90 days prior to the day of screening

* Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
* History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
* History of diabetic ketoacidosis

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 (adequate contraceptive measure as required by local regulation or practice).For certain specific countries: Additional specific requirements apply
* Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
* Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
* History of pancreatitis (acute or chronic)
* History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
* Any of the following: myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening
* Subjects presently classified as being in New York Heart Association Class IV
* Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
* Subjects with ALT (alanine aminotransferase) above 2.5 x upper normal limit
* Renal impairment defined as Estimated Glomerular Filtration Rate below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula (CKD-EPI)
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

Tuscumbia, Alabama, United States

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Encino, California, United States

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La Mesa, California, United States

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Northridge, California, United States

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Palm Springs, California, United States

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Poway, California, United States

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Riverside, California, United States

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Spring Valley, California, United States

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Bradenton, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Oviedo, Florida, United States

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Atlanta, Georgia, United States

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Perry, Georgia, United States

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Meridian, Idaho, United States

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Peoria, Illinois, United States

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Evansville, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Rockville, Maryland, United States

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Boston, Massachusetts, United States

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Buckley, Michigan, United States

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Kalamazoo, Michigan, United States

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Butte, Montana, United States

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Albany, New York, United States

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Northport, New York, United States

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Wilmington, North Carolina, United States

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Cincinnati, Ohio, United States

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Mason, Ohio, United States

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Philadelphia, Pennsylvania, United States

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Greer, South Carolina, United States

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Humboldt, Tennessee, United States

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Kingsport, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Katy, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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CABA, , Argentina

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Capital Federal, , Argentina

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Córdoba, , Argentina

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Córdoba, , Argentina

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São Paulo, São Paulo, Brazil

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Porto Alegre, , Brazil

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São Paulo, , Brazil

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Karlovac, , Croatia

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Krapinske Toplice, , Croatia

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Pula, , Croatia

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Virovitica, , Croatia

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Zagreb, , Croatia

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Zagreb, , Croatia

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Athens, , Greece

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Athens, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Budapest, , Hungary

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Cegléd, , Hungary

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Nyíregyhaza, , Hungary

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Salgótarján, , Hungary

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Szekszárd, , Hungary

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Bologna, , Italy

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Lucca, , Italy

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Palermo, , Italy

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Roma, , Italy

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Roma, , Italy

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Siena, , Italy

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Bialystok, , Poland

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Lublin, , Poland

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Puławy, , Poland

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Warsaw, , Poland

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Wroclaw, , Poland

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Zabrze, , Poland

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Kazan', , Russia

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Moscow, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Tyumen, , Russia

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Kragujevac, , Serbia

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Niš, , Serbia

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Novi Sad, , Serbia

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Almería, , Spain

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Centelles (Barcelona), , Spain

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L'Hospitalet de Llobregat, , Spain

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La Roca Del Vallés, , Spain

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Pozuelo de Alarcón, , Spain

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Seville, , Spain

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Seville, , Spain

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Valencia, , Spain

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Vic (Barcelona), , Spain

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Bangkok, , Thailand

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Bangkoknoi, Bangkok, , Thailand

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Countries

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United States Argentina Brazil Croatia Greece Hungary Italy Poland Russia Serbia Spain Thailand

References

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Rodbard HW, Rosenstock J, Canani LH, Deerochanawong C, Gumprecht J, Lindberg SO, Lingvay I, Sondergaard AL, Treppendahl MB, Montanya E; PIONEER 2 Investigators. Oral Semaglutide Versus Empagliflozin in Patients With Type 2 Diabetes Uncontrolled on Metformin: The PIONEER 2 Trial. Diabetes Care. 2019 Dec;42(12):2272-2281. doi: 10.2337/dc19-0883. Epub 2019 Sep 17.

Reference Type RESULT
PMID: 31530666 (View on PubMed)

Eliasson B, Ericsson A, Fridhammar A, Nilsson A, Persson S, Chubb B. Long-Term Cost Effectiveness of Oral Semaglutide Versus Empagliflozin and Sitagliptin for the Treatment of Type 2 Diabetes in the Swedish Setting. Pharmacoecon Open. 2022 May;6(3):343-354. doi: 10.1007/s41669-021-00317-z. Epub 2022 Jan 21.

Reference Type RESULT
PMID: 35064550 (View on PubMed)

Aroda VR, Bauer R, Christiansen E, Haluzik M, Kallenbach K, Montanya E, Rosenstock J, Meier JJ. Efficacy and safety of oral semaglutide by subgroups of patient characteristics in the PIONEER phase 3 programme. Diabetes Obes Metab. 2022 Jul;24(7):1338-1350. doi: 10.1111/dom.14710. Epub 2022 May 9.

Reference Type RESULT
PMID: 35373893 (View on PubMed)

Pulleyblank R, Larsen NB. Cost-Effectiveness of Semaglutide vs. Empagliflozin, Canagliflozin, and Sitagliptin for Treatment of Patients with Type 2 Diabetes in Denmark: A Decision-Analytic Modelling Study. Pharmacoecon Open. 2023 Jul;7(4):579-591. doi: 10.1007/s41669-023-00416-z. Epub 2023 May 13.

Reference Type DERIVED
PMID: 37178435 (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)

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)

Thethi TK, Pratley R, Meier JJ. Efficacy, safety and cardiovascular outcomes of once-daily oral semaglutide in patients with type 2 diabetes: The PIONEER programme. Diabetes Obes Metab. 2020 Aug;22(8):1263-1277. doi: 10.1111/dom.14054. Epub 2020 May 13.

Reference Type DERIVED
PMID: 32267058 (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)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

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2015-005209-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

U1111-1176-6006

Identifier Type: OTHER

Identifier Source: secondary_id

NN9924-4223

Identifier Type: -

Identifier Source: org_study_id

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