Brief Summary

This trial is conducted globally. The aim of this trial is to investigate efficacy and safety of oral semaglutide versus placebo in subjects with type 2 diabetes mellitus treated with diet and exercise only.

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

703

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Sep 2016

Geographic Reach

11 countries

105 active sites

Status

completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

September 15, 2016

Completed

5 days until next milestone

First Posted

Study publicly available on registry

September 20, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

September 20, 2016

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2017

Completed

2.2 years 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

1.1 years

First QC Date

September 15, 2016

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

Secondary Outcomes (47)

Change in Body Weight (kg)
Week 0, week 26
Change in Fasting Plasma Glucose
Week 0, week 26
Change in Mean 7-point SMPG Profile
Week 0, week 26
Change in Mean Postprandial Increment Over All Meals in SMPG
Week 0, week 26
Change in Fasting Insulin - Ratio to Baseline
Week 0, week 26
+42 more secondary outcomes

Study Arms (4)

3 mg oral semaglutide

EXPERIMENTAL

Drug: semaglutide

7 mg oral semaglutide

EXPERIMENTAL

Drug: semaglutide

14 mg oral semaglutide

EXPERIMENTAL

Drug: semaglutide

Placebo

PLACEBO COMPARATOR

Drug: placebo

Interventions

semaglutideDRUG

Oral administration once daily.

14 mg oral semaglutide3 mg oral semaglutide7 mg oral semaglutide

placeboDRUG

Oral administration once daily.

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.