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



Status:Active, not recruiting
Conditions:Obesity Weight Loss, Obesity Weight Loss
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:1/9/2019
Start Date:June 4, 2018
End Date:May 4, 2020

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Effect and Safety of Semaglutide 2.4 mg Once-weekly in Subjects With Overweight or Obesity and Type 2 Diabetes

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


Inclusion Criteria:

- Male or female, age greater than or equal to 18 years at the time of signing informed
consent

- 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) (both
inclusive)) 180 days or longer prior to the day of screening

Exclusion Criteria:

- A self-reported change in body weight greater than 5 kg (11 lbs) within 90 days before
screening irrespective of medical records

- Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of less
than 30 mL/min/1.73 m^2 (less than 60 ml/min/1.73 m^2 in subjects treated with
Sodium-glucose Cotransporter 2 Inhibitors) according to chronic kidney disease
(CKD)-Epidemiology Collaboration (EPI) creatinine equation as defined by Kidney
Disease: Improving Global Outcomes (KDIGO) 2012 by the central laboratory at screening

- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by
a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist
or an equally qualified health care provider (e.g. optometrist) within the past 90
days prior to screening or in the period between screening and randomisation
We found this trial at
45
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Wadsworth, Ohio 44281
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Anderson, South Carolina 29621
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Atlanta, Georgia 30318
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Austin, Texas 78731
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Bristol, Tennessee 37620
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Butte, Montana 59701
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Chapel Hill, North Carolina 27599
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Chicago, Illinois 60612
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Clearwater, Florida 33756
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Concord, California 94520
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Dallas, Texas 75231
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Des Moines, Iowa 50314
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Fresno, California 93702
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Golden, Colorado 80401
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Greensboro, North Carolina 27408
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Greenville, North Carolina 27834
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Hawaiian Gardens, California 90716
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Hickory, North Carolina 28602
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Houston, Texas 77030
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Jacksonville, Florida 32207
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Kissimmee, Florida 34744
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Lawrenceville, New Jersey 08648
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Lexington, Kentucky 40503
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Lomita, California 90717
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Los Angeles, California 90027
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Louisville, Kentucky 40213
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Minneapolis, Minnesota 55404
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Mission Hills, California 91345
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Mount Pleasant, South Carolina 29464
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Nashville, Tennessee 37203
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Olive Branch, Mississippi 38654
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Olympia, Washington 98502
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Roswell, Georgia 30076
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Saint George, Utah 84790
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Saint Petersburg, Florida 33713
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Salisbury, North Carolina 28144
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Shavano Park, Texas 78231
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Spring Valley, California 91978
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Springfield, Illinois 62702
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Tampa, Florida 33612
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Tarzana, California 91356
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Topeka, Kansas 66606
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Wilmington, North Carolina 28401
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Winchester, Virginia 22601
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