Brief Summary

This trial is conducted in Asia, Europe and North America. The aim of the trial is to compare the effect of semaglutide s.c. 1.0 mg once-weekly versus placebo as add-on to sodium glucose co-transporter-2 inhibitor (SGLT-2i) monotherapy or in combination with either metformin or sulfonylurea on glycaemic control after 30 weeks of treatment in subjects with type 2 diabetes. Subjects will remain on their pre-trial medication.

Trial Health

On Track

Trial Health Score

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

Enrollment

302

participants targeted

Target at P25-P50 for phase_3 diabetes

Timeline

Completed

Started Mar 2017

Typical duration for phase_3 diabetes

Geographic Reach

7 countries

72 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

1.4 years study duration

First Submitted

Initial submission to the registry

March 14, 2017

Completed

1 day until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed

7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2017

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2018

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 6, 2018

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 20, 2019

Completed

Last Updated

July 2, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

March 14, 2017

Results QC Date

July 2, 2019

Last Update Submit

July 1, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) in HbA1c was evaluated at week 30. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product and ended at the first date of any of the following: 1) the last dose of trial product + 7 days or 2) initiation of rescue medication.
Week 0, week 30

Secondary Outcomes (57)

Change in Body Weight (kg)
Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean 7-point Profile
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7-point Profile: Mean Post Prandial Increment (Over All Meals)
Week 0, week 30
Change in Fasting Blood Lipid, Total Cholesterol
Week 0, week 30
+52 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Drug: Semaglutide

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SemaglutideDRUG

Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Semaglutide

PlaceboDRUG

Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks

Placebo

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, above or equal to 18 years at the time of signing informed consent. For Japan only: Male or female, age equal to or above 20 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus
HbA1c of 7.0-10.0% (53-86 mmol/mol) (both inclusive)
Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (equal to or above 1500 mg or maximum tolerated dose) or a SU for at least 90 days prior to the day of screening. All medications in compliance with current local label

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)
Any disorder which in the investigator's opinion might jeopardise subject's safety or compliance with the protocol
Subjects with alanine aminotransferase above 2.5 x upper normal limit
Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative
History or presence of pancreatitis (acute or chronic)
History of diabetic ketoacidosis
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina 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 Class IV
Planned coronary, carotid or peripheral artery revascularisation known on the day of screening
Renal impairment measured as estimated Glomerular Filtration Rate value of eGFR below 60 ml/min/1.73 m\^2 as defined by KDIGO 2012 classification using isotope dilution mass spectrometry for serum creatinine measured at screening
Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation
Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed

Contact the study team to confirm eligibility.