Diabetes Mellitus, Type 2Phase 3SUSTAIN SWITCHNCT04287179
SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in 4 countries.
Trial summary
This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Semaglutide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 25 sitesin 4 countries
- Study dates
- 9 Mar 2020to 25 Jan 2021
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
25 sites in 4 countries.
25 sites in 4 countries
United States14 sites
Novo Nordisk Investigational Site
Albany, New York, 12206
Novo Nordisk Investigational Site
Buena Park, California, 90620
Novo Nordisk Investigational Site
Dallas, Texas, 75390-9302
Novo Nordisk Investigational Site
Fresno, California, 93720
Novo Nordisk Investigational Site
Honolulu, Hawaii, 96814
Novo Nordisk Investigational Site
Idaho Falls, Idaho, 83404-7596
Novo Nordisk Investigational Site
Indianapolis, Indiana, 46260
Novo Nordisk Investigational Site
Round Rock, Texas, 78681
Novo Nordisk Investigational Site
San Jose, California, 95148
Novo Nordisk Investigational Site
Sugar Land, Texas, 77478
Novo Nordisk Investigational Site
Troy, Michigan, 48098
Novo Nordisk Investigational Site
Walnut Creek, California, 94598
Novo Nordisk Investigational Site
Waterbury, Connecticut, 06708
Novo Nordisk Investigational Site
West Seneca, New York, 14224
Finland5 sites
Novo Nordisk Investigational Site
Jyväskylä, 40100
Novo Nordisk Investigational Site
Kuopio, 70100
Novo Nordisk Investigational Site
Lahti, 15100
Novo Nordisk Investigational Site
Raisio, 21200
Novo Nordisk Investigational Site
Seinäjoki, 60220
Austria4 sites
Novo Nordisk Investigational Site
Graz, 8036
Novo Nordisk Investigational Site
Stockerau, 2000
Novo Nordisk Investigational Site
Vienna, 1090
Novo Nordisk Investigational Site
Vienna, 1130
Sweden2 sites
Novo Nordisk Investigational Site
Gothenburg, 413 45
Novo Nordisk Investigational Site
Malmö, 205 02
About this study
Official title: 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
This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Semaglutide
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SemaglutideDrug
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
| Study group | Role | What they receive |
|---|---|---|
| Semaglutide 0.50 mg | Experimental | Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg. Receives: Drug: Semaglutide |
| Semaglutide 0.25 mg | Active comparator | Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg. Receives: Drug: Semaglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glycosylated haemoglobin (HbA1c)
Percent-point
Measured: From baseline (week 0) to week 12
Secondary outcomes (7)
Change in fasting plasma glucose
mmol/L
Measured: From baseline (week 0) to week 12
Change in body weight
Kg
Measured: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Count
Measured: From baseline (week 0) to week 12
Number of treatment emergent gastrointestinal adverse events
Count
Measured: From baseline (week 0) to week 12
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Count
Measured: From baseline (week 0) to week 12
Change in pulse rate
Beats per minute (bpm)
Measured: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Count
Measured: From week 12 to week 17
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2020
- Study start9 Mar 2020
- Primary completion16 Nov 2020 (estimated)
- Study completion25 Jan 2021 (estimated)
Why it stopped: COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Reporting Anchor & Disclosure (1452), Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04287179
- Sponsor's protocol ID
- NN9535-4650
- Other IDs
- U1111-1242-5426, 2019-004234-42, 2019
- Acronym
- SUSTAIN SWITCH
- Status last verified
- Feb 2022
- First submitted
- 25 Feb 2020
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04287179
- Acronym / sponsor ID
- SUSTAIN SWITCH / NN9535-4650
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected. In parallel, the development of a new type of pen injector, which was an important part of the trial, was ceased and thus this trial was cancelled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- 9 Mar 2020 (actual)
- Primary completion
- 16 Nov 2020 (estimated)
- Study completion
- 25 Jan 2021 (estimated)
- First posted
- 27 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the effect and safety of 2 dose schedules for semaglutide (study medicine) in people with type 2 diabetes previously treated with a diabetes medicine similar to semaglutide. The study will also evaluate the use of a new pen-injector for semaglutide used to inject medicine under the skin, at a new dose of 2 mg. People taking part in the study will take this medicine together with their current diabetes tablets other than semaglutide. Participants will either get a start dose of 0.25 mg semaglutide or 0.50 mg semaglutide, and the dose will be gradually increased to 2.0 mg semaglutide - which treatment is decided by chance. Participants will inject semaglutide under the skin once a week, any time of the day. When the dose reaches 2.0 mg semaglutide, participants will inject the medicine with a new type of pen-injector. The study will last for about 24 weeks. Participants will have 9 visits and 1 phone call with the study doctor. At 9 visits participants will have blood taken and at 2 visits they will have eye examination done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Women who are able to get pregnant will be checked 10 times for pregnancy via urine tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Semaglutide 0.50 mg | Experimental | Drug: SemaglutideOnce-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg. |
| Semaglutide 0.25 mg | Active comparator | Drug: SemaglutideOnce-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SemaglutideDose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period. | Drug | Semaglutide 0.25 mg, Semaglutide 0.50 mg |
Primary outcome
Change in glycosylated haemoglobin (HbA1c)
Time frame: From baseline (week 0) to week 12
Percent-point
7 secondary outcomes
Change in fasting plasma glucose
Time frame: From baseline (week 0) to week 12
Change in body weight
Time frame: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Time frame: From baseline (week 0) to week 12
Number of treatment emergent gastrointestinal adverse events
Time frame: From baseline (week 0) to week 12
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
Time frame: From baseline (week 0) to week 12
Change in pulse rate
Time frame: From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
Time frame: From week 12 to week 17
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Individual participant dataSharing planned: Yes. According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Reporting Anchor & Disclosure (1452) study director
Novo Nordisk A/S
25 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Semaglutide in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 25 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States, Finland, Austria, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in glycosylated haemoglobin (HbA1c) (time frame: From baseline (week 0) to week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022.