SUSTAIN SWITCH

WithdrawnPhase 3

SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes

Effect and Safety of Two Different Dose-escalation Regimens for Once-weekly Semaglutide s.c. in Subjects With Type 2 Diabetes Mellitus Previously Treated With GLP-1 RAs

Lead sponsor

Novo Nordisk A/S

Asset

Semaglutide

GLP-1 agonist

Listed sites

Recruiting sites

—

Enrollment

—

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 6.5-10%

Primary endpoint

•HbA1c, change

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04287179

Org study IDNN9535-4650

Secondary ID2019-004234-42European Medicines Agency (EudraCT)

Secondary IDU1111-1242-5426World Health Organization (WHO)

Timeline

Milestones

Study first posted2020-02-27actual

Study start2020-03-09actual

Primary completion2020-11-16estimated

Study completion2021-01-25estimated

Last update posted2022-02-03actual

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female, age 18 years or older at the time of signing informed consent.

•Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.

•The need and willingness to change prior GLP-1 RA treatment to once-weekly semaglutide s.c., as assessed by the investigator.

•HbA1c of 6.5-10% (48-86 mmol/mol) (both inclusive).

•Treatment with any therapeutic dose of GLP-1 RA other than once-weekly semaglutide s.c., as defined in the local label, with or without OADs (metformin, DPP-4 inhibitor, SU, glinide, thiazolidinedione, SGLT-2 inhibitor or alpha-glucosidase inhibitor). All doses of antidiabetic treatments should have been stable for at least 90 days prior to the day of the screening, at investigator's discretion.

Exclusion criteria

•Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.

•Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than 30 mL/min/1.73 m2 according to 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

Endpoints (8)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

Weight & body composition

Cardiometabolic biomarkers

Weight & body composition

1 endpoint

Secondary/protocol endpoint

Change in body weight

Time frame:From baseline (week 0) to week 12

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints

Primary/protocol endpoint

Change in glycosylated haemoglobin (HbA1c)

Time frame:From baseline (week 0) to week 12

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in fasting plasma glucose

Time frame:From baseline (week 0) to week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

1 endpoint

Secondary/protocol endpoint

Change in pulse rate

Time frame:From baseline (week 0) to week 12

Heart rate, change

change from baseline, improvement

Safety / tolerability / PK

4 endpoints

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From baseline (week 0) to week 12

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of treatment emergent gastrointestinal adverse events

Time frame:From baseline (week 0) to week 12

event count, event

Secondary/protocol endpoint

Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes

Time frame:From baseline (week 0) to week 12

Documented hypoglycemia

event count, event

componentsSevere hypoglycemia, Documented hypoglycemia

Secondary/protocol endpoint

Number of treatment emergent adverse events (TEAEs)

Time frame:From week 12 to week 17

Treatment-emergent AEs (any)

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.