Brief Summary

This trial is globally conducted. The aim of this trial is to investigate Efficacy and Safety of Oral Semaglutide Using a Flexible Dose Adjustment Based on Clinical Evaluation versus Sitagliptin in Subjects with Type 2 Diabetes Mellitus.

Trial Health

On Track

Trial Health Score

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

Enrollment

504

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Sep 2016

Longer than P75 for phase_3 diabetes

Geographic Reach

10 countries

83 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

2.5 years study duration

First Submitted

Initial submission to the registry

July 21, 2016

Completed

8 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed

2 months until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed

1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2019

Completed

11 months until next milestone

Results Posted

Study results publicly available

February 17, 2020

Completed

Last Updated

July 20, 2022

Status Verified

July 1, 2022

Enrollment Period

1.4 years

First QC Date

July 21, 2016

Results QC Date

October 15, 2019

Last Update Submit

July 11, 2022

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Participants Who Achieve HbA1c <7.0% (53 mmol/Mol) ADA Target (Yes/no)
Participants who achieved HbA1c \<7.0% (American Diabetes Association (ADA) target) (yes/no), was evaluated at week 52. 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 52

Secondary Outcomes (68)

Change in Body Weight
Week 0, week 52
Change in HbA1c
Week 0, week 52
Change in FPG
Week 0, week 52
Change in Body Weight (%)
Week 0, week 52
Change in BMI
Week 0, Week 52
+63 more secondary outcomes

Study Arms (2)

Semaglutide flexible dosing (3, 7 or 14 mg)

EXPERIMENTAL

Drug: semaglutide

Sitagliptin 100 mg

ACTIVE COMPARATOR

Drug: sitagliptin

Interventions

semaglutideDRUG

Oral administration once-daily.

Semaglutide flexible dosing (3, 7 or 14 mg)

sitagliptinDRUG

Oral administration once-daily.

Sitagliptin 100 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

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 above or equal to 18 years at the time of signing informed consent. For Korea only: Male or female, age above or equal to 19 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus for at least 90 days prior to day of screening
HbA1c (glycosylated haemoglobin) 7.5-9.5% (58-80 mmol/mol) (both inclusive)
Treatment target of HbA1c below 7.0% (53 mmol/mol), as judged by the investigator
Stable daily dose(s) of 1-2 of the following anti-diabetic drugs within 90 days prior to the day of screening:
Metformin (equal or above 1500 mg or maximum tolerated dose as documented in the subject medical record)
Sulfonylureas (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
Sodium glucose co-transporter 2 inhibitors
Thiazolidinediones (equal or above half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)
Extension phase:
Informed consent for the extension phase obtained before any trial-related activities for the extension phase.
On randomised treatment with or without rescue medication at week 52.

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 an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). For certain specific countries: Additional specific requirements apply
Any disorder, which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
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 hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and randomisation
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
Subjects with alanine aminotransferase above 2.5 x upper normal limit
Renal impairment defined as Estimated Glomerular Filtration rate 60 mL/min/1.73 m\^2 as per Chronic Kidney Disease Epidemiology Collaboration formula
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation
History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ)
History of diabetic ketoacidosis

Contact the study team to confirm eligibility.