Brief Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to compare the effect of once-weekly dosing of two dose levels of semaglutide versus sitagliptin 100 mg once-daily on glycaemic control after 30 weeks of treatment. Subjects will remain on their stable pre-trial metformin.

Trial Health

On Track

Trial Health Score

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

Enrollment

868

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Aug 2017

Typical duration for phase_3 diabetes

Geographic Reach

7 countries

67 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

1.6 years study duration

First Submitted

Initial submission to the registry

February 17, 2017

Completed

6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed

6 months until next milestone

Study Start

First participant enrolled

August 28, 2017

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2019

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2019

Completed

12 months until next milestone

Results Posted

Study results publicly available

April 9, 2020

Completed

Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

1.5 years

First QC Date

February 17, 2017

Results QC Date

March 9, 2020

Last Update Submit

February 11, 2021

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period and 'in trial' observation period. 'On-treatment without rescue medication' observation period: started at the date of first dose to either the day of last dose plus 7 days or first initiation of rescue medication, whichever came first. 'In-trial' observation period: started when a participant was randomised until the final scheduled visit, including any period after initiation of rescue medication or premature treatment discontinuation.
Week 0, week 30

Secondary Outcomes (73)

Change in Body Weight
Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG) - Mean 7-point Profile
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG) - Mean Postprandial Increment Over All Meals
Week 0, week 30
Change in Fasting Insulin - Ratio to Baseline
Week 0, week 30
+68 more secondary outcomes

Study Arms (4)

Semaglutide 0.5 mg OW + sitagliptin placebo OD

EXPERIMENTAL

Drug: Semaglutide 0.5 mgDrug: Sitagliptin placebo

Semaglutide 1 mg OW + sitagliptin placebo OD

EXPERIMENTAL

Drug: Semaglutide 1.0 mgDrug: Sitagliptin placebo

Sitagliptin OD + semaglutide placebo 0.5 mg OW

ACTIVE COMPARATOR

Drug: SitagliptinDrug: Semaglutide placebo 0.5 mg

Sitagliptin OD + semaglutide placebo 1 mg OW

ACTIVE COMPARATOR

Drug: SitagliptinDrug: Semaglutide placebo 1.0 mg

Interventions

Semaglutide 0.5 mgDRUG

Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks

Semaglutide 0.5 mg OW + sitagliptin placebo OD

Semaglutide 1.0 mgDRUG

Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks

Semaglutide 1 mg OW + sitagliptin placebo OD

Sitagliptin placeboDRUG

Sitagliptin placebo tablets taken once-daily for 30 weeks

Semaglutide 0.5 mg OW + sitagliptin placebo ODSemaglutide 1 mg OW + sitagliptin placebo OD

SitagliptinDRUG

100 mg sitagliptin tablets taken once-daily for 30 weeks

Sitagliptin OD + semaglutide placebo 0.5 mg OWSitagliptin OD + semaglutide placebo 1 mg OW

Semaglutide placebo 0.5 mgDRUG

Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks

Sitagliptin OD + semaglutide placebo 0.5 mg OW

Semaglutide placebo 1.0 mgDRUG

Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks

Sitagliptin OD + semaglutide placebo 1 mg OW

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.