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Clinical Trials List

Protocol NumberNN9535-4114
NCT Number(ClinicalTrials.gov Identfier)NCT03061214

2017-08-28 - 2019-10-02

Phase III

Terminated3

ICD-10E11

Type 2 diabetes mellitus

ICD-9250.00

Diabetes mellitus without mention of complication, Type II [non-insulin dependent type][NIDDM type] [ adult-onset type] or unspecified type, not stated as uncontrolled

Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes A 30-week randomised, double-blind, double-dummy, active-controlled, parallel-group, multi-centre and multi-national trial

  • Trial Applicant

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Sponsor

    NOVO NORDISK PHARMA (TAIWAN) LTD.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/09/15

Investigators and Locations

Principal Investigator Harn-Shen Chen Division of Endocrinology
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

28 Stop recruiting

Audit

None

Principal Investigator 謝昌勳 Division of Endocrinology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Principal Investigator Yu-Yao Huang
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Stop recruiting

Audit

None

Condition/Disease

Diabetes Diabetes Mellitus, Type 2

Objectives

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.

Test Drug

Semaglutide

Active Ingredient

Semaglutide

Dosage Form

Solution for injection

Dosage

1.34 mg/mL

Endpoints

Change in HbA1c Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation. Week 0, week 30

Inclution 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

The Estimated Number of Participants

  • Taiwan

    50 participants

  • Global

    858 participants

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