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Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

NCT ID: NCT03191396

Last Updated: 2019-10-15

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

577 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-27

Study Completion Date

2018-08-13

Brief Summary

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This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

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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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Semaglutide

Half the study participants are randomised to receive semaglutide

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Liraglutide

Half the study participants are randomised to receive liraglutide

Group Type ACTIVE_COMPARATOR

Liraglutide

Intervention Type DRUG

Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Interventions

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Semaglutide

Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Intervention Type DRUG

Liraglutide

Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion Criteria: - Male or female, age 18 years or older at the time of signing informed consent - Diagnosed with type 2 diabetes mellitus - HbA1c of 7.0-11.0 % (53 - 97 mmol/mol) (both inclusive) - Stable daily dose(s) including any of the following anti-diabetic drug(s) or combination regimens 90 days prior to the day of screening: a) Biguanides (metformin above or equal to 1500 mg or maximum tolerated dose documented in the subject's medical record). b) Sulphonylureas (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record).

Exclusion Criteria

c) SGLT-2 inhibitors (above or equal to half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) Exclusion Criteria: - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - History or presence of pancreatitis (acute or chronic) - History of diabetic ketoacidosis - Any of the following: myocardial infarction, stroke, hospitalization 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 (NYHA) Class IV - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening - Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of below 30 ml/min/1.73 sqm as defined by KDIGO 2012 classification - Impaired liver function, defined as ALT above or equal to 2.5 times upper normal limit at screening - Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
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

Burgas, , Bulgaria

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Novo Nordisk Investigational Site

Dupnitsa, , Bulgaria

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Novo Nordisk Investigational Site

Lukovit, , Bulgaria

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Madan, , Bulgaria

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Petrich, , Bulgaria

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Rousse, , Bulgaria

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Sliven, , Bulgaria

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Sofia, , Bulgaria

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Vratsa, , Bulgaria

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Brno, , Czechia

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Brno, , Czechia

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Náchod, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Helsinki, , Finland

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Jyväskylä, , Finland

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Kuusamo, , Finland

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Lahti, , Finland

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Oulu, , Finland

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Rauma, , Finland

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Turku, , Finland

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Varkaus, , Finland

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Béziers, , France

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Dambach-la-Ville, , France

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Dijon, , France

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La Rochelle, , France

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Le Coudray, , France

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Le Creusot, , France

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Nantes, , France

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Obernai, , France

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Paris, , France

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Paris, , France

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Perpignan, , France

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Schiltigheim, , France

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Strasbourg, , France

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Vandœuvre-lès-Nancy, , France

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Vénissieux, , France

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Dresden, , Germany

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Essen, , Germany

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Falkensee, , Germany

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Hamburg, , Germany

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Saint Ingbert-Oberwürzbach, , Germany

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Stuttgart, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Nagykanizsa, , Hungary

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Pécs, , Hungary

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Siófok, , Hungary

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Szolnok, , Hungary

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Tatabánya, , Hungary

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Zalaegerszeg, , Hungary

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Bergamo, , Italy

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Como, , Italy

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Milan, , Italy

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Pavia, , Italy

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Rome, , Italy

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Lublin, , Poland

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Lublin, , Poland

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Szczecin, , Poland

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Celje, , Slovenia

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Jesenice, , Slovenia

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Koper, , Slovenia

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Ljubljana, , Slovenia

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Alcorcón, , Spain

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Almería, , Spain

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La Roca Del Vallés, , Spain

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Palma de Mallorca, , Spain

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Valladolid, , Spain

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Vic (Barcelona), , Spain

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Ängelholm, , Sweden

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Kristianstad, , Sweden

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Lund, , Sweden

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Örebro, , Sweden

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Stockholm, , Sweden

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Stockholm, , Sweden

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Blackpool, , United Kingdom

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Bristol, , United Kingdom

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Coventry, , United Kingdom

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Crewe, , United Kingdom

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Faringdon, , United Kingdom

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Hinckley, , United Kingdom

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London, , United Kingdom

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Northwood, , United Kingdom

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Norwich, , United Kingdom

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Nuneaton, , United Kingdom

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Rhyl, , United Kingdom

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Rotherham, , United Kingdom

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Sidcup, , United Kingdom

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Southampton, , United Kingdom

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St Helens, , United Kingdom

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Truro, , United Kingdom

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Novo Nordisk Investigational Site

Watford, , United Kingdom

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Countries

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Bulgaria Czechia Finland France Germany Hungary Italy Poland Slovenia Spain Sweden United Kingdom

References

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Capehorn MS, Catarig AM, Furberg JK, Janez A, Price HC, Tadayon S, Verges B, Marre M. Efficacy and safety of once-weekly semaglutide 1.0mg vs once-daily liraglutide 1.2mg as add-on to 1-3 oral antidiabetic drugs in subjects with type 2 diabetes (SUSTAIN 10). Diabetes Metab. 2020 Apr;46(2):100-109. doi: 10.1016/j.diabet.2019.101117. Epub 2019 Sep 17.

Reference Type RESULT
PMID: 31539622 (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)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2016-004965-22

Identifier Type: REGISTRY

Identifier Source: secondary_id

U1111-1190-5868

Identifier Type: OTHER

Identifier Source: secondary_id

NN9535-4339

Identifier Type: -

Identifier Source: org_study_id

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