Brief Summary

This trial is conducted globally. The aim of the trial is to investigate the efficacy and safety of oral semaglutide versus placebo in subjects with Type 2 Diabetes Mellitus treated with insulin. All subjects should continue their pre-trial insulin therapy (basal, basal-bolus or premixed regimen including combinations of soluble insulins) throughout the trial. Subjects treated with metformin in addition to insulin treatment must continue their metformin treatment throughout the entire trial.

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

731

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Feb 2017

Typical duration for phase_3 diabetes

Geographic Reach

10 countries

118 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

1.6 years study duration

First Submitted

Initial submission to the registry

January 12, 2017

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2017

Completed

20 days until next milestone

Study Start

First participant enrolled

February 2, 2017

Completed

12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 18, 2018

Completed

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 22, 2018

Completed

1.2 years until next milestone

Results Posted

Study results publicly available

November 7, 2019

Completed

Last Updated

March 2, 2020

Status Verified

February 1, 2020

Enrollment Period

12 months

First QC Date

January 12, 2017

Results QC Date

October 15, 2019

Last Update Submit

February 14, 2020

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 data from the in-trial observation period. In-trial observation period started at the date of randomisation and included the period after initiation of rescue medication and/or premature trial product discontinuation, if any. The endpoint was also analysed based on data from the on-treatment without rescue medication observation period. On-treatment without rescue medication observation period started at the date of the first dose of trial product and includes the period after initiation of rescue medication, if any, and excludes the period after premature trial discontinuation, if any.
Week 0, week 26

Secondary Outcomes (36)

Change in Body Weight (Week 26)
Week 0, week 26
Change in HbA1c (Week 52)
Week 0, week 52
Change in Body Weight (kg) (Week 52)
Week 0, week 52
Change in Fasting Plasma Glucose (FPG)
Week 0, week 26, week 52
Change in Self-measured Plasma Glucose (SMPG) Mean 7-point Profile
Week 0, week 26, week 52
+31 more secondary outcomes

Study Arms (4)

Semaglutide 3 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 3 mg + 7 mg

EXPERIMENTAL

Drug: semaglutide

Semaglutide 3 mg + 7 mg + 14 mg

EXPERIMENTAL

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutideDRUG

Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Semaglutide 3 mg

placeboDRUG

Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.