NCT03191396|CompletedPhase 3ResultsFDA Drug

Research Study Comparing a New Medicine Semaglutide to Liraglutide in People With Type 2 Diabetes

SUSTAIN 10

Efficacy and Safety of Semaglutide 1.0 mg Once-weekly Versus Liraglutide 1.2 mg Once-daily as add-on to 1-3 Oral Anti-diabetic Drugs (OADs) in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

Compare

3 other identifiers

NN9535-43392016-004965-22U1111-1190-5868

Study Type

interventional

Target

577

Locations

12 countries

Sites

Timeline

RegisteredJun 2017

StartedJun 2017

CompletionAug 2018

Brief Summary

This study is conducted in Europe. The aim of the study is to compare the effect of semaglutide subcutaneous (s.c., under the skin) 1.0 mg once-weekly to liraglutide s.c.1.2 mg once-daily on blood sugar levels after 30 weeks of treatment in people with type 2 diabetes. The study will last approximately 9 months (37 weeks). Each participant will have 7 visits at the clinic and 3 phone calls with the study doctor. At the visits, participants will have a number of tests, for example: general health checks, blood samples, heart and eye checks etc. Participants will also fill in some forms about their health and satisfaction with their diabetes treatment.

Trial Health

On Track

Trial Health Score

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

Enrollment

577

participants targeted

Target at P50-P75 for phase_3 diabetes

Timeline

Completed

Started Jun 2017

Geographic Reach

12 countries

92 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

1.1 years study duration

First Submitted

Initial submission to the registry

June 16, 2017

Completed

3 days until next milestone

First Posted

Study publicly available on registry

June 19, 2017

Completed

8 days until next milestone

Study Start

First participant enrolled

June 27, 2017

Completed

1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 9, 2018

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2018

Completed

1 year until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed

Last Updated

October 15, 2019

Status Verified

October 1, 2019

Enrollment Period

1 year

First QC Date

June 16, 2017

Results QC Date

July 8, 2019

Last Update Submit

October 2, 2019

Conditions

Diabetes Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Mean change from baseline (week 0) to week 30 in glycosylated haemoglobin (HbA1c) %. The endpoint was evaluated based on the 'on-treatment without rescue medication period' where subjects were considered treated with trial product, but had not yet initiated rescue medication. Missing data were imputed using observed data from subjects within the same group defined by randomised treatment, using a regression model including stratification factor as categorical effect and data from baseline and all previous visits as covariates.
Week 0, week 30

Secondary Outcomes (40)

Change in Body Weight (kg)
Week 0, week 30
Change in Fasting Plasma Glucose (FPG)
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean 7-point Profile
Week 0, week 30
Change in Self-measured Plasma Glucose (SMPG), 7 Point Profile: Mean Post Prandial Increment (Over All Meals)
Week 0, week 30
Change in Fasting Blood Lipids: Total Cholesterol
Week 0, week 30
+35 more secondary outcomes

Study Arms (2)

Semaglutide

EXPERIMENTAL

Half the study participants are randomised to receive semaglutide

Drug: Semaglutide

Liraglutide

ACTIVE COMPARATOR

Half the study participants are randomised to receive liraglutide

Drug: Liraglutide

Interventions

SemaglutideDRUG

Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any

Semaglutide

LiraglutideDRUG

Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any

Liraglutide

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

Contact the study team to confirm eligibility.