Brief Summary

This trial is conducted in Africa, Asia, Europe, North and South America. The aim of the trial is to compare the effect of once-weekly (OW) dosing of subcutaneous semaglutide (1.0 mg) versus once-daily dosing of oral canagliflozin (300 mg) on glycaemic control in subjects with type 2 diabetes (T2D) on a background treatment of metformin

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

788

participants targeted

Target at P75+ for phase_3 diabetes

Timeline

Completed

Started Mar 2017

Typical duration for phase_3 diabetes

Geographic Reach

12 countries

119 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

1.7 years study duration

First Submitted

Initial submission to the registry

March 14, 2017

Completed

1 day until next milestone

Study Start

First participant enrolled

March 15, 2017

Completed

2 months until next milestone

First Posted

Study publicly available on registry

May 2, 2017

Completed

1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2018

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2018

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

December 17, 2019

Completed

Last Updated

January 21, 2020

Status Verified

January 1, 2020

Enrollment Period

1.6 years

First QC Date

March 14, 2017

Results QC Date

October 15, 2019

Last Update Submit

January 8, 2020

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) to week 52 in HbA1c (glycosylated haemoglobin) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which 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; and 'In-trial' observation period which started at the date of randomisation and include the period after initiation of rescue medication and/or premature trial product discontinuation, if any and ended at the last contact, withdrawal of consent or death, whichever came first.
Week 0, week 52

Secondary Outcomes (60)

Change in Body Weight (kg)
Week 0, week 52
Change in Total Fat Mass (kg)
Week 0, week 52
Change in FPG (Fasting Plasma Glucose)
Week 0, week 52
Change in SMPG (Self-measured Plasma Glucose)- Mean 7-point Profile
Week 0, week 52
Change in SMPG- Mean Postprandial Increment Over All Meals
Week 0, week 52
+55 more secondary outcomes

Study Arms (2)

Semaglutide + canagliflozin placebo

EXPERIMENTAL

Drug: SemaglutideDrug: Placebo (canagliflozin)

Canagliflozin + semaglutide placebo

ACTIVE COMPARATOR

Drug: CanagliflozinDrug: Placebo (semaglutide)

Interventions

SemaglutideDRUG

Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.

Semaglutide + canagliflozin placebo

CanagliflozinDRUG

Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.

Canagliflozin + semaglutide placebo

Placebo (canagliflozin)DRUG

Semaglutide + canagliflozin placebo

Placebo (semaglutide)DRUG

Canagliflozin + semaglutide placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.