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A Research Study to Compare Two Doses of Semaglutide Taken Once Weekly in People With Type 2 Diabetes (SUSTAIN FORTE)

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ClinicalTrials.gov Identifier: NCT03989232
Recruitment Status : Completed
First Posted : June 18, 2019
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:
This study compares the effect of two doses of semaglutide (1.0 mg and 2.0 mg) in people with type 2 diabetes (T2D). People taking part in the study will take the medicine together with their current diabetes medicine (sulphonylurea and/or metformin). Participants will get a dose of either 1.0 mg or 2.0 mg semaglutide once a week - which dose is decided by chance. Participants will inject semaglutide under the skin once a week. The study will last for about 49 weeks. Participants will have 9 clinic visits and 2 phone calls with the study doctor. At the visits participants will have blood taken and eye tests done. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period. Female participants who can get pregnant will be checked 11 times for pregnancy via urine tests.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 961 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Sponsor staff involved in the clinical trial is masked according to company standard procedures
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Semaglutide 2.0 mg s.c. Once-weekly Compared to Semaglutide 1.0 mg s.c. Once-weekly in Subjects With Type 2 Diabetes
Actual Study Start Date : June 19, 2019
Actual Primary Completion Date : September 18, 2020
Actual Study Completion Date : November 9, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Semaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: Semaglutide 2.0 mg
All participants will receive one injection per week during a 12-week dose escalation period, until the target dose for semaglutide 2.0 mg is reached. From week 13 to week 40, semaglutide will be given in two weekly injections of 1.0 mg each.
 Drug: Semaglutide
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.
Active Comparator: Semaglutide 1.0 mg
All participants will receive one injection per week during a 12-week dose escalation period. From week 13 to week 40, the 1.0 mg group will receive an additional injection of semaglutide placebo in order to maintain the blinding.
 Drug: Semaglutide
Semaglutide injected subcutaneously (s.c., under the skin) once-weekly. Participants will keep taking their pre-study diabetes tablets throughout the study.

Drug: Placebo (semaglutide)
Semaglutide placebo injected once-weekly from week 13 to week 40.


Outcome Measures
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Primary Outcome Measures :
  1. Change in HbA1c [ Time Frame: From baseline (week 0) to week 40 ]
    Percent-point


Secondary Outcome Measures :
  1. Change in body weight (kg) [ Time Frame: From baseline (week 0) to week 40 ]
    kg

  2. Change in fasting plasma glucose (FPG) [ Time Frame: From baseline (week 0) to week 40 ]
    mmol/l

  3. Change in body mass index (BMI) [ Time Frame: From baseline (week 0) to week 40 ]
    kg/m^2

  4. Change in waist circumference [ Time Frame: From baseline (week 0) to week 40 ]
    cm

  5. HbA1c below 7% [ Time Frame: At week 40 ]
    Yes/no

  6. HbA1c equal to or below 6.5% [ Time Frame: At week 40 ]
    Yes/no

  7. Weight loss equal to or above 5% [ Time Frame: At week 40 ]
    Yes/no

  8. Weight loss equal to or above 10% [ Time Frame: At week 40 ]
    Yes/no

  9. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes [ Time Frame: From first dose (week 0) to week 40 ]
    Count

  10. Change in pulse rate [ Time Frame: From baseline (week 0) to week 40 ]
    bpm


Eligibility Criteria
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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 equal to or above18 years at the time of signing informed consent
  • Diagnosed with T2D at least 180 days prior to the day of screening
  • HbA1c of 8-10% (64-86 mmol/mol) (both inclusive)
  • Stable daily dose(s) for 90 days prior to the day of screening of:
  • Any metformin formulations (equal to or above1500 mg or maximum tolerated or effective dose) alone or in combination with sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)

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 <30 mL/min/1.73 m^2 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
Contacts and Locations
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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): NCT03989232


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03989232    
Other Study ID Numbers: NN9535-4506
U1111-1224-5162 ( Other Identifier: World Health Organization (WHO) )
2018-004529-96 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: June 18, 2019    Key Record Dates
Last Update Posted: March 12, 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