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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 (SUSTAIN SWITCH)

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ClinicalTrials.gov Identifier: NCT04287179
Recruitment Status : Withdrawn (COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected.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.)
First Posted : February 27, 2020
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Semaglutide Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 9, 2020
Estimated Primary Completion Date : November 16, 2020
Estimated Study Completion Date : January 25, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arm Intervention/treatment
Experimental: 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.
Drug: Semaglutide
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.

Active Comparator: 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.
Drug: Semaglutide
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.




Primary Outcome Measures :
  1. Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 12 ]
    Percent-point


Secondary Outcome Measures :
  1. Change in fasting plasma glucose [ Time Frame: From baseline (week 0) to week 12 ]
    mmol/L

  2. Change in body weight [ Time Frame: From baseline (week 0) to week 12 ]
    Kg

  3. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 12 ]
    Count

  4. Number of treatment emergent gastrointestinal adverse events [ Time Frame: From baseline (week 0) to week 12 ]
    Count

  5. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [ Time Frame: From baseline (week 0) to week 12 ]
    Count

  6. Change in pulse rate [ Time Frame: From baseline (week 0) to week 12 ]
    Beats per minute (bpm)

  7. Number of treatment emergent adverse events (TEAEs) [ Time Frame: From week 12 to week 17 ]
    Count



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287179


Locations
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United States, California
Novo Nordisk Investigational Site
Buena Park, California, United States, 90620
Novo Nordisk Investigational Site
Fresno, California, United States, 93720
Novo Nordisk Investigational Site
San Jose, California, United States, 95148
Novo Nordisk Investigational Site
Walnut Creek, California, United States, 94598
United States, Connecticut
Novo Nordisk Investigational Site
Waterbury, Connecticut, United States, 06708
United States, Hawaii
Novo Nordisk Investigational Site
Honolulu, Hawaii, United States, 96814
United States, Idaho
Novo Nordisk Investigational Site
Idaho Falls, Idaho, United States, 83404-7596
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Michigan
Novo Nordisk Investigational Site
Troy, Michigan, United States, 48098
United States, New York
Novo Nordisk Investigational Site
Albany, New York, United States, 12206
Novo Nordisk Investigational Site
West Seneca, New York, United States, 14224
United States, Texas
Novo Nordisk Investigational Site
Dallas, Texas, United States, 75390-9302
Novo Nordisk Investigational Site
Round Rock, Texas, United States, 78681
Novo Nordisk Investigational Site
Sugar Land, Texas, United States, 77478
Austria
Novo Nordisk Investigational Site
Graz, Austria, 8036
Novo Nordisk Investigational Site
Stockerau, Austria, 2000
Novo Nordisk Investigational Site
Wien, Austria, 1090
Novo Nordisk Investigational Site
Wien, Austria, 1130
Finland
Novo Nordisk Investigational Site
Jyväskylä, Finland, 40100
Novo Nordisk Investigational Site
Kuopio, Finland, 70100
Novo Nordisk Investigational Site
Lahti, Finland, 15100
Novo Nordisk Investigational Site
Raisio, Finland, 21200
Novo Nordisk Investigational Site
Seinäjoki, Finland, 60220
Sweden
Novo Nordisk Investigational Site
Göteborg, Sweden, 413 45
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04287179    
Other Study ID Numbers: NN9535-4650
U1111-1242-5426 ( Other Identifier: World Health Organization (WHO) )
2019-004234-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: March 9, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases