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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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Recruitment Status : Withdrawn (COVID19 impact on this trial was evaluated and a delay of at least 6-9 months was expected.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

Tracking Information
First Submitted Date  ICMJE February 25, 2020
First Posted Date  ICMJE February 27, 2020
Last Update Posted Date March 9, 2021
Actual Study Start Date  ICMJE March 9, 2020
Estimated Primary Completion Date November 16, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
Change in glycosylated haemoglobin (HbA1c) [ Time Frame: From baseline (week 0) to week 12 ]
Percent-point
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 25, 2020)
  • Change in fasting plasma glucose [ Time Frame: From baseline (week 0) to week 12 ]
    mmol/L
  • Change in body weight [ Time Frame: From baseline (week 0) to week 12 ]
    Kg
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From baseline (week 0) to week 12 ]
    Count
  • Number of treatment emergent gastrointestinal adverse events [ Time Frame: From baseline (week 0) to week 12 ]
    Count
  • Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [ Time Frame: From baseline (week 0) to week 12 ]
    Count
  • Change in pulse rate [ Time Frame: From baseline (week 0) to week 12 ]
    Beats per minute (bpm)
  • Number of treatment emergent adverse events (TEAEs) [ Time Frame: From week 12 to week 17 ]
    Count
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE SUSTAIN SWITCH: A Research Study to Compare Two Dose Schedules of Semaglutide Taken Once Weekly in People With Type 2 Diabetes
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE Drug: Semaglutide
Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Semaglutide
  • 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.
    Intervention: Drug: Semaglutide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: December 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: February 25, 2020)
160
Estimated Study Completion Date  ICMJE January 25, 2021
Estimated Primary Completion Date November 16, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Finland,   Sweden,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04287179
Other Study ID Numbers  ICMJE NN9535-4650
U1111-1242-5426 ( Other Identifier: World Health Organization (WHO) )
2019-004234-42 ( Registry Identifier: European Medicines Agency (EudraCT) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials. com
URL: http://novonordisk-trials.com
Responsible Party Novo Nordisk A/S
Study Sponsor  ICMJE Novo Nordisk A/S
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Reporting Anchor & Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP