Overview

Efficacy and Safety of Semaglutide Once-weekly Versus Sitagliptin Once-daily as add-on to Metformin in Subjects With Type 2 Diabetes (SUSTAIN - CHINA MRCT)

Status:
Completed

Trial end date:
2019-04-15

Target enrollment:
0

Participant gender:
All

Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Novo Nordisk A/S

Treatments:

Metformin
Sitagliptin Phosphate

Criteria

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 equal to
or above 18 years at the time of signing informed consent - Subjects diagnosed with type 2
diabetes and on stable treatment in a period of 60 days prior to screening with metformin
equal to or above 1500 mg (or maximum tolerated dose equal to or above 1000 mg). Stable is
defined as unchanged medication and unchanged daily dose - HbA1c 7.0 - 10.5 % (53-91
mmol/mol) (both inclusive) Exclusion Criteria: - Female who is pregnant, breast-feeding or
intends to become pregnant or is of childbearing potential not using an adequate
contraceptive method throughout the trial including the 5 week follow-up period (adequate
contraceptive measure as required by local regulation or practice) - Any disorder 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 60 days before screening. An exception is short-term treatment
(equal to or below 7 days 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