NCT04287179|WithdrawnPhase 3FDA Drug

Study 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.

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

SUSTAIN SWITCH

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

Novo Nordisk A/S ClinicalTrials.gov

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3 other identifiers

NN9535-4650U1111-1242-54262019-004234-42

Study Type

interventional

Target

N/A

Locations

4 countries

Sites

Timeline

RegisteredFeb 2020

StartedMar 2020

CompletionJan 2021

Brief 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. 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.

Trial Health

At Risk

Trial Health Score

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

Trial has exceeded expected completion date

Timeline

Completed

Started Mar 2020

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach

4 countries

25 active sites

Status

withdrawn

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

11 months study duration

First Submitted

Initial submission to the registry

February 25, 2020

Completed

2 days until next milestone

First Posted

Study publicly available on registry

February 27, 2020

Completed

11 days until next milestone

Study Start

First participant enrolled

March 9, 2020

Completed

8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2020

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2021

Completed

Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

8 months

First QC Date

February 25, 2020

Last Update Submit

February 2, 2022

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

Change in glycosylated haemoglobin (HbA1c)
Percent-point
From baseline (week 0) to week 12

Secondary Outcomes (7)

Change in fasting plasma glucose
From baseline (week 0) to week 12
Change in body weight
From baseline (week 0) to week 12
Number of treatment emergent adverse events (TEAEs)
From baseline (week 0) to week 12
Number of treatment emergent gastrointestinal adverse events
From baseline (week 0) to week 12
Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes
From baseline (week 0) to week 12
+2 more secondary outcomes

Study Arms (2)

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.

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.

Drug: Semaglutide

Interventions

SemaglutideDRUG

Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.

Semaglutide 0.25 mgSemaglutide 0.50 mg

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

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

You may qualify if:

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.

You may not qualify if:

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

Contact the study team to confirm eligibility.