Research Study Investigating How Well Semaglutide Works in People With Type 2 Diabetes Suffering From Overweight or Obesity

Last updated: November 8, 2021
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Obesity

Diabetes Prevention

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT03552757
NN9536-4374
2017-003414-10
U1111-1200-8148
  • Ages > 18
  • All Genders

Study Summary

This study will look at the change in the participant's body weight from the start to the end of the study. This is to compare the effect on body weight in people taking semaglutide (a new medicine) and people taking "dummy" medicine. In addition to taking the study medicine, the participant will have talks with study staff about healthy food choices, how to be more physically active and what else the participant can do to lose weight. Overweight and obesity is associated with an increased risk of type 2 diabetes. Therefore, weight loss has shown to have a beneficial impact on the blood sugar levels. The participant will either get semaglutide or "dummy" medicine - which treatment the participant get is decided by chance. The participant will need to take 2 injections at the same time once a week. The study medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm. The study will last for about 1.5 years

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male or female, age greater than or equal to 18 years at the time of signing informedconsent
  • Body Mass Index (BMI) greater than or equal to 27 kg/m^2 '
  • History of at least one self-reported unsuccessful dietary effort to lose body weight
  • Diagnosed with type 2 diabetes (haemoglobin A1c 7-10% (53-86 mmol/mol) (bothinclusive)) 180 days or longer prior to the day of screening

Exclusion

Exclusion Criteria:

  • A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days beforescreening irrespective of medical records
  • Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of lessthan 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated withSodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease (CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by KidneyDisease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening
  • Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified bya pharmacologically pupil-dilated fundus examination performed by an ophthalmologistor an equally qualified health care provider (e.g. optometrist) within the past 90days prior to screening or in the period between screening and randomisation

Study Design

Total Participants: 1210
Study Start date:
June 04, 2018
Estimated Completion Date:
May 01, 2020

Connect with a study center

  • Novo Nordisk Investigational Site

    Algiers, 16000
    Algeria

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    Oran, 31000
    Algeria

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    Caba, C1060ABA
    Argentina

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    Chacabuco, B6740ELF
    Argentina

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    Córdoba, X5016KEH
    Argentina

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    Mendoza, 5500
    Argentina

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    Santiago del Estero, G4200
    Argentina

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    Calgary, Alberta T2V 4J2
    Canada

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    Mount Pearl, Newfoundland and Labrador A1N 1W7
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    Concord, Ontario L4K 4M2
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    Hamilton, Ontario L8J 0B6
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    London, Ontario N5W 6A2
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    Stoney Creek, Ontario L8J 0B6
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    Thornhill, Ontario L4J 8L7
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    Toronto, Ontario M9V 4B4
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    Montreal, Quebec H1M 1B1
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    St-Marc-des-Carrières, Quebec G0A 4B0
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    Essen, 45136
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    Hamburg, 22041
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    Lingen, 49808
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    Tochigi, 323-0022
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    Glasgow, G31 2ER
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