Brief Summary

This trial is conducted in Asia, Europe and the United States of America (USA). The aim of the trial is to investigate efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes.

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

1,201

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Jan 2016

Typical duration for phase_3 diabetes

Geographic Reach

17 countries

209 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

1.4 years study duration

First Submitted

Initial submission to the registry

January 5, 2016

Completed

1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2016

Completed

Same day until next milestone

Study Start

First participant enrolled

January 6, 2016

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2017

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 19, 2017

Completed

12 months until next milestone

Results Posted

Study results publicly available

May 8, 2018

Completed

Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1.3 years

First QC Date

January 5, 2016

Results QC Date

April 9, 2018

Last Update Submit

October 2, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Results are based on HbA1c data from on-treatment without rescue medication observation period. The 'on-treatment' observation period was the period where the subject was considered to be exposed to trial product. The 'on-treatment without rescue medication' observation period was a subset of the 'on-treatment' observation period, where subjects did not receive any non-investigational antidiabetic medication (rescue medication). This period includes the observations recorded at, or after the date of first dose of trial product and not after the first occurrence of the following: the end-date of the 'on-treatment' observation period or initiation of rescue medication. The post-baseline responses are analysed using a mixed model for repeated measurements with treatment and country as fixed factors and baseline value as covariate, all nested within visit.
Week 0, week 40

Secondary Outcomes (27)

Change in Body Weight (kg)
Week 0, week 40
Change in Fasting Plasma Glucose
Week 0, week 40
Change in Systolic and Diastolic Blood Pressure
Week 0, week 40
Change in Overall Scores for Patient Reported Outcomes: Diabetes Treatment Satisfaction Questionnaire
Week 0, week 40
HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists Target
After 40 weeks treatment
+22 more secondary outcomes

Study Arms (4)

Semaglutide 0.5 mg/Week

EXPERIMENTAL

Drug: semaglutide

Semaglutide 1.0 mg/Week

EXPERIMENTAL

Drug: semaglutide

Dulaglutide 0.75 mg/Week

ACTIVE COMPARATOR

Drug: Dulaglutide

Dulaglutide 1.5 mg/Week

ACTIVE COMPARATOR

Drug: Dulaglutide

Interventions

semaglutideDRUG

Administered subcutaneously (s.c., under the skin) once-weekly.

Semaglutide 0.5 mg/WeekSemaglutide 1.0 mg/Week

DulaglutideDRUG

Administered subcutaneously (s.c., under the skin) once-weekly.

Dulaglutide 0.75 mg/WeekDulaglutide 1.5 mg/Week

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.