Efficacy and Safety of Semaglutide Versus Dulaglutide as add-on to Metformin in Subjects With Type 2 Diabetes. (SUSTAIN 7)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Diabetes; Diabetes Mellitus, Type 2

Treatments: Drug: Dulaglutide; Drug: semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT02648204

2014-005375-91 (EudraCT Number)

NN9535-4216

U1111-1164-8495 (Other Identifier)

Details and patient eligibility

About

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

Enrollment: 1,201 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria: - Male or female, age at least 18 years at the time of signing informed consent. - HbA1c (glycosylated haemoglobin) 7.0 - 10.5% (53 - 91 mmol/mol) (both inclusive) - Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening 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 measures as required by local regulation or practice) - Any condition, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of equal to or below 14 days - History of pancreatitis (acute or chronic) - Screening calcitonin equal to or above 50 ng/L - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - Renal impairment defined as eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Subjects presently classified as being in New York Heart Association Class IV - Planned coronary, carotid or peripheral artery revascularisation on the day of screening - Proliferative retinopathy or maculopathy requiring acute treatment - History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas) - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,201 participants in 4 patient groups

Semaglutide 0.5 mg/Week

Experimental group

Treatment:

Drug: semaglutide

Semaglutide 1.0 mg/Week

Experimental group

Treatment:

Drug: semaglutide

Dulaglutide 0.75 mg/Week

Active Comparator group

Treatment:

Drug: Dulaglutide

Dulaglutide 1.5 mg/Week

Active Comparator group

Treatment:

Drug: Dulaglutide