Brief Summary

This trial is conducted globally. The aim of the trial is to investigate efficacy and long-term safety of oral semaglutide versus sitagliptin in subjects with type 2 diabetes.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network

Enrollment

1,864

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Feb 2016

Longer than P75 for phase_3 diabetes

Geographic Reach

15 countries

242 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.1 years study duration

First Submitted

Initial submission to the registry

November 10, 2015

Completed

8 days until next milestone

First Posted

Study publicly available on registry

November 18, 2015

Completed

3 months until next milestone

Study Start

First participant enrolled

February 15, 2016

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2017

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2018

Completed

1.9 years until next milestone

Results Posted

Study results publicly available

February 27, 2020

Completed

Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1 year

First QC Date

November 10, 2015

Results QC Date

October 15, 2019

Last Update Submit

July 11, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c: Week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 26. The endpoint was evaluated based on the data from the in-trial observation period, which was the time period from when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication and/or premature discontinuation of trial product. The endpoint was also evaluated based on the data from the on-treatment without rescue medication observation period, which was the time period when a participant was on treatment with trial product, excluding any period after initiation of rescue medication and/or premature trial product discontinuation.
Week 0, week 26

Secondary Outcomes (42)

Change in Body Weight: Week 26
Week 0, week 26
Change in HbA1c: Weeks 52 and 78
Week 0, week 52, week 78
Change in Body Weight (kg): Weeks 52 and 78
Week 0, week 52, week 78
Change in Body Weight (%)
Week 0, week 26, week 52, week 78
Change in FPG
Week 0, week 26, week 52, week 78
+37 more secondary outcomes

Study Arms (4)

Semaglutide 3 mg

EXPERIMENTAL

Drug: semaglutideDrug: placebo

Semaglutide 7 mg

EXPERIMENTAL

Drug: semaglutideDrug: placebo

Semaglutide 14 mg

EXPERIMENTAL

Drug: semaglutideDrug: placebo

Sitagliptin 100 mg

ACTIVE COMPARATOR

Drug: sitagliptinDrug: placebo

Interventions

semaglutideDRUG

Oral administration once-daily

Semaglutide 14 mgSemaglutide 3 mgSemaglutide 7 mg

sitagliptinDRUG

Oral administration once-daily

Sitagliptin 100 mg

placeboDRUG

Oral administration once-daily

Semaglutide 14 mgSemaglutide 3 mgSemaglutide 7 mgSitagliptin 100 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Male or female, age at least 18 years at the time of signing informed consent For Japan only: Male or female, age at least 20 years at the time of signing informed consent
Diagnosed with T2DM (type 2 diabetes mellitus) for at least 90 days prior to day of screening
HbA1c (glycosylated haemoglobin) 7.0-10.5 % (53-91 mmol/mol) (both inclusive).
Stable daily dose of metformin (equal or above 1500 mg or maximum tolerated dose as documented in subject medical record) alone or in combination with SU (= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record) within 90 days prior to the day of screening

You may not qualify if:

Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC)
History of pancreatitis (acute or chronic)
History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery)
Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/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 defined as estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)

Contact the study team to confirm eligibility.