NCT03989232|CompletedPhase 3ResultsFDA Drug

A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

SUSTAIN FORTE

Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9535-4506U1111-1224-51622018-004529-96

Study Type

interventional

Target

961

Locations

11 countries

Sites

129

Timeline

RegisteredJun 2019

StartedJun 2019

CompletionNov 2020

Brief Summary

This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

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

961

participants targeted

Target at P75+ for phase_3 diabetes-mellitus-type-2

Timeline

Completed

Started Jun 2019

Geographic Reach

11 countries

129 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

1.4 years study duration

First Submitted

Initial submission to the registry

June 14, 2019

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed

1 day until next milestone

Study Start

First participant enrolled

June 19, 2019

Completed

1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2020

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed

12 months until next milestone

Results Posted

Study results publicly available

October 22, 2021

Completed

Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

1.3 years

First QC Date

June 14, 2019

Results QC Date

August 4, 2021

Last Update Submit

February 10, 2023

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in HbA1c
Change from baseline (week 0) to week 40 in glycosylated haemoglobin (HbA1c) was evaluated. Results are based on the 'on-treatment without rescue medication' observation period, which started at the date of first dose of trial product to either first initiation of rescue medication or the day of last dose of trial product, whichever came first; and 'In-trial' observation period which started at the date of randomisation and ended at the first of the following dates, both inclusive: end-of-treatment visit (week 40), death, participant withdrew informed consent, last contact for participant lost to follow-up.
Week 0, week 40

Secondary Outcomes (10)

Change in Body Weight
Week 0, week 40
Change in Fasting Plasma Glucose (FPG)
Week 0, week 40
Change in Body Mass Index (BMI)
Week 0, week 40
Change in Waist Circumference
Week 0, week 40
Participants Who Achieved HbA1c < 7.0%
Week 40
+5 more secondary outcomes

Study Arms (2)

Semaglutide 2.0 mg

EXPERIMENTAL

All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.

Drug: Semaglutide

Semaglutide 1.0 mg

ACTIVE COMPARATOR

All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.

Drug: SemaglutideDrug: Placebo (semaglutide)

Interventions

SemaglutideDRUG

Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Semaglutide 1.0 mgSemaglutide 2.0 mg

Placebo (semaglutide)DRUG

Semaglutide placebo injected once-weekly from week 13 to week 40.

Semaglutide 1.0 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

Male or female, age equal to or above18 years at the time of signing informed consent
Diagnosed with T2D at least 180 days prior to the day of screening
HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)
Stable daily dose(s) for 90 days prior to the day of screening of:
Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

You may not qualify if:

Renal impairment measured as estimated glomerular filtration rate (eGFR) value of \<30 mL/min/1.73 m\^2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKDEPI) creatinine equation as defined by KDIGO 2012 classification
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination

Contact the study team to confirm eligibility.