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Search / Trial NCT03689374

A Research Study to Compare Semaglutide to Insulin Aspart, When Taken Together With Metformin and Insulin Glargine, in People With Type 2 Diabetes

Launched by NOVO NORDISK A/S · Sep 27, 2018

Trial Information

Current as of October 08, 2025

Completed

Keywords

ClinConnect Summary

No description provided

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Male or female, age greater than or equal to 18 years at the time of signing informed consent
  • Diagnosed with type 2 diabetes greater than or equal to 180 days prior to the day of screening
  • Treated with basal insulin once daily or twice daily for greater than or equal to 90 days prior to the day of screening
  • Stable daily dose for 90 days prior to the day of screening of the following anti-diabetic drugs or combination regimens: Any metformin formulations (greater than or equal to 1500 mg to less than or equal to 3000 mg or maximum tolerated or effective dose documented in subject's medical record), alone or in combination (including fixed-dose drug combination) with up to one additional of the following oral antidiabetic drugs: sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors or alpha-glucosidase inhibitors
  • Glycated haemoglobin (HbA1c) of greater than 7.5% to less than or less than or equal to 10.0% (greater than 58 mmol/mol to less than or equal to 86 mmol/mol)
  • Exclusion Criteria:
  • History or presence of pancreatitis (acute or chronic)
  • 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 Class IV
  • Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
  • Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term bolus insulin treatment for a maximum of 14 days prior to the day of screening is allowed
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or an equally qualified health care provider (for example, optometrist) within the past 90 days prior to run-in

About Novo Nordisk A/S

Novo Nordisk A/S is a global healthcare company headquartered in Denmark, specializing in the research, development, manufacturing, and marketing of innovative pharmaceuticals, particularly in the fields of diabetes care, obesity treatment, and hormone replacement therapies. With a strong commitment to improving patient outcomes, Novo Nordisk invests significantly in clinical trials to advance scientific knowledge and develop effective therapies. The company is dedicated to sustainability and ethical practices, striving to deliver high-quality healthcare solutions while addressing the evolving needs of patients worldwide. Through collaboration and innovation, Novo Nordisk aims to lead the way in transforming diabetes and other chronic diseases into manageable conditions.

Locations

Bad Kreuznach, Germany

Friedrichsthal, Germany

Rehlingen Siersburg, Germany

New Dehli, New Delhi, India

Bratislava, Slovakia

Presov, Slovakia

Madrid, Spain

Münster, Germany

Córdoba, Spain

Pohlheim, Germany

Lublin, Poland

Zabrze, Poland

Galati, Romania

Plovdiv, Bulgaria

Zagreb, Croatia

Porto, Portugal

Bad Mergentheim, Germany

Schwabenheim, Germany

Rijeka, Croatia

Varna, Bulgaria

Osijek, Croatia

Athens, Greece

Chandigarh, Punjab, India

Ankara, Turkey

Gyula, Hungary

Zalaegerszeg, Hungary

Mumbai, Maharashtra, India

Cluj Napoca, Cluj, Romania

Durban, Kwazulu Natal, South Africa

Hohenmölsen, Germany

Wroclaw, Poland

Palma De Mallorca, Spain

Szeged, Hungary

Siedlce, Poland

Indore, Madhya Pradesh, India

Lubochna, Slovakia

Erzurum, Turkey

Adana, Turkey

Schweinfurt, Germany

Pulawy, Poland

Falkensee, Germany

Koper, Slovenia

Hamburg, Germany

Jaipur, Rajasthan, India

Madurai, Tamil Nadu, India

Kolkata, West Bengal, India

Johannesburg, Gauteng, South Africa

Antalya, Turkey

Karlovac, Croatia

Pécs, Hungary

Belgrade, Serbia

Nis, Serbia

Novi Sad, Serbia

Eisenach, Germany

Esslingen, Germany

Dimitrovgrad, Bulgaria

Ruse, Bulgaria

Stara Zagora, Bulgaria

Kragujevac, Serbia

Antequera, Spain

Sevilla, Spain

Bangalore, Karnataka, India

Málaga, Spain

Denizli, Turkey

Burgas, Bulgaria

Brezice, Slovenia

Saint Ingbert Oberwürzbach, Germany

Villingen Schwenningen, Germany

Ruda Slaska, Poland

Targu Mures, Mures, Romania

Lenasia, Gauteng, South Africa

Izmir, Turkey

Bialystok, Poland

Umkomaas, Kwazulu Natal, South Africa

Varazdin, Croatia

Skopje, North Macedonia

Alexandroupolis, Greece

Thessaloniki, Greece

Nagpur, Maharashtra, India

New Delhi, India

Coimbra, Portugal

Lisboa, Portugal

Hyderabad, Andhra Pradesh, India

Ludhiana, Punjab, India

Hyderbad, Telengana, India

Braga, Portugal

Delhi, New Delhi, India

Brno, Czechia

Pune, Maharashtra, India

Zajecar, Serbia

Piraeus, Greece

Essen, Germany

Almada, Portugal

Salgótarján, Hungary

Benoni, Gauteng, South Africa

Istanbul, Turkey

Larissa, Greece

Bardejov, Slovakia

Dolny Kubin, Slovakia

Levice, Slovakia

Prievidza, Slovakia

Bhubaneswar, Orissa, India

Mohali, Punjab, India

Poznan, Poland

Ogre, Latvia

Riga, Latvia

Kaunas, Lithuania

Segovia, Spain

Ahmedabad, Gujarat, India

Jerichow, Germany

Pretoria, Gauteng, South Africa

Sabinov, Slovakia

Olomouc, Czechia

Prostejov, Czechia

Fuenlabrada Madrid, Spain

Nachod, Czechia

Plzeň, Czechia

Cosmo City, Gauteng, South Africa

Trabzon, Turkey

Panevezys, Lithuania

Vilnius, Lithuania

Brasov, Romania

Oldenburg I. Holst, Germany

Murska Sobota, Slovenia

Pula, Croatia

Nagykanizsa, Hungary

Mlada Boleslav, Czechia

Targoviste, Dambovita, Romania

Ploiesti, Prahova, Romania

Pärnu, Estonia

Tallinn, Estonia

Viljandi, Estonia

Warsaw, Poland

Budapest, Hungary

Jesenice, Slovenia

Skorzewo, Poland

Almeria, Spain

Banja Luka, Bosnia And Herzegovina

Sarajevo, Bosnia And Herzegovina

Tuzla, Bosnia And Herzegovina

Byala, Bulgaria

Sofia, Bulgaria

Beroun, Czechia

Kladno Krocehlavy, Czechia

Berlin, Germany

Kiel Kronshagen, Germany

Leipzig, Germany

Stuhr, Germany

Stuttgart, Germany

Jelgava, Latvia

Sigulda, Latvia

Talsi, Latvia

Gorzow Wielkopolski, Poland

Lodz, Poland

Wierzchoslawice, Poland

Loures, Portugal

Setubal, Portugal

Martin, Slovakia

Nova Gorica, Slovenia

Patients applied

0 patients applied

Trial Officials

Clinical Reporting Anchor and Disclosure (1452)

Study Director

Novo Nordisk A/S

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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