Brief Summary

This trial is conducted in Africa, Asia, Europe and South America. The aim of the trial is to evaluate efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin and/or TZD (thiazolidinedione) 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

1,231

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Dec 2013

Typical duration for phase_3 diabetes

Geographic Reach

18 countries

141 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

1.9 years study duration

First Submitted

Initial submission to the registry

August 23, 2013

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed

3 months until next milestone

Study Start

First participant enrolled

December 2, 2013

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2015

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 12, 2015

Completed

3.2 years until next milestone

Results Posted

Study results publicly available

January 7, 2019

Completed

Last Updated

June 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1.9 years

First QC Date

August 23, 2013

Results QC Date

December 14, 2017

Last Update Submit

May 28, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c (Glycosylated Haemoglobin) From Baseline
Change in HbA1c from baseline until week 56.Full analysis set (FAS=1225) included all randomised subjects who had received at least one dose of randomised semaglutide or sitagliptin.
Week 0, week 56

Secondary Outcomes (5)

Change in Body Weight From Baseline
Week 0, week 56
Change in Fasting Plasma Glucose (FPG) From Baseline
Week 0, week 56
Change in Systolic and Diastolic Blood Pressure From Baseline
Week 0, week 56
Change in Patient Reported Outcome (PRO) Questionnaire Diabetes Treatment Satisfaction Questionnaire Status (DTSQs) From Baseline
Week 0, week 56
Subjects Who Achieved HbA1c Below or Equal to 6.5% (48 mmol/Mol) American Association of Clinical Endocrinologists (AACE) Target (Yes/no)
After 56 weeks treatment

Study Arms (4)

Semaglutide 0.5 mg + sitagliptin placebo

EXPERIMENTAL

Drug: semaglutideDrug: placebo

Semaglutide 1.0 mg + sitagliptin placebo

EXPERIMENTAL

Drug: semaglutideDrug: placebo

Sitagliptin 100 mg + semaglutide placebo 1.0 mg

ACTIVE COMPARATOR

Drug: sitagliptinDrug: placebo

Sitagliptin 100 mg + semaglutide placebo 0.5 mg

ACTIVE COMPARATOR

Drug: sitagliptinDrug: placebo

Interventions

semaglutideDRUG

For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.

Semaglutide 0.5 mg + sitagliptin placeboSemaglutide 1.0 mg + sitagliptin placebo

sitagliptinDRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Sitagliptin 100 mg + semaglutide placebo 0.5 mgSitagliptin 100 mg + semaglutide placebo 1.0 mg

placeboDRUG

Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.

Semaglutide 0.5 mg + sitagliptin placeboSemaglutide 1.0 mg + sitagliptin placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.