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

NCT ID: NCT04287179

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-09

Study Completion Date

2021-01-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Semaglutide 0.50 mg

Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.50 mg.

Group Type EXPERIMENTAL

Semaglutide

Intervention Type DRUG

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

Semaglutide 0.25 mg

Once-weekly semaglutide administered subcutaneously (s.c., under the skin) with or without oral antidiabetics (OADs). Start dose 0.25 mg.

Group Type ACTIVE_COMPARATOR

Semaglutide

Intervention Type DRUG

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

Interventions

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Semaglutide

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

Intervention Type DRUG

Eligibility Criteria

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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.

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novo Nordisk A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Reporting Anchor & Disclosure (1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

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Novo Nordisk Investigational Site

Buena Park, California, United States

Site Status

Novo Nordisk Investigational Site

Fresno, California, United States

Site Status

Novo Nordisk Investigational Site

San Jose, California, United States

Site Status

Novo Nordisk Investigational Site

Walnut Creek, California, United States

Site Status

Novo Nordisk Investigational Site

Waterbury, Connecticut, United States

Site Status

Novo Nordisk Investigational Site

Honolulu, Hawaii, United States

Site Status

Novo Nordisk Investigational Site

Idaho Falls, Idaho, United States

Site Status

Novo Nordisk Investigational Site

Indianapolis, Indiana, United States

Site Status

Novo Nordisk Investigational Site

Troy, Michigan, United States

Site Status

Novo Nordisk Investigational Site

Albany, New York, United States

Site Status

Novo Nordisk Investigational Site

West Seneca, New York, United States

Site Status

Novo Nordisk Investigational Site

Dallas, Texas, United States

Site Status

Novo Nordisk Investigational Site

Round Rock, Texas, United States

Site Status

Novo Nordisk Investigational Site

Sugar Land, Texas, United States

Site Status

Novo Nordisk Investigational Site

Graz, , Austria

Site Status

Novo Nordisk Investigational Site

Stockerau, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Vienna, , Austria

Site Status

Novo Nordisk Investigational Site

Jyväskylä, , Finland

Site Status

Novo Nordisk Investigational Site

Kuopio, , Finland

Site Status

Novo Nordisk Investigational Site

Lahti, , Finland

Site Status

Novo Nordisk Investigational Site

Raisio, , Finland

Site Status

Novo Nordisk Investigational Site

Seinäjoki, , Finland

Site Status

Novo Nordisk Investigational Site

Gothenburg, , Sweden

Site Status

Novo Nordisk Investigational Site

Malmo, , Sweden

Site Status

Countries

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United States Austria Finland Sweden

Other Identifiers

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U1111-1242-5426

Identifier Type: OTHER

Identifier Source: secondary_id

2019-004234-42

Identifier Type: REGISTRY

Identifier Source: secondary_id

NN9535-4650

Identifier Type: -

Identifier Source: org_study_id

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