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
sites
Lomita, California 90717
2600
mi
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Lomita, CA
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Algiers,
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Anderson, South Carolina 29621
826
mi
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Anderson, SC
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Atlanta, Georgia 30318
934
mi
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Atlanta, GA
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Austin, Texas 78731
1691
mi
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Austin, TX
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Bristol, Tennessee 37620
712
mi
from 02139
Bristol, TN
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Butte, Montana 59701
2044
mi
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Butte, MT
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Chapel Hill, North Carolina 27599
616
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from 02139
Chapel Hill, NC
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Chicago, Illinois 60612
847
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Chicago, IL
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Clearwater, Florida 33756
1192
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Clearwater, FL
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Concord, California 94520
2663
mi
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Concord, CA
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Dallas, Texas 75231
1541
mi
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Dallas, TX
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Des Moines, Iowa 50314
1154
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Des Moines, IA
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Fresno, California 93702
2585
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Fresno, CA
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Golden, Colorado 80401
1774
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Golden, CO
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Greensboro, North Carolina 27408
635
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Greensboro, NC
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Greenville, North Carolina 27834
574
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Greenville, NC
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Hawaiian Gardens, California 90716
2586
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Hawaiian Gardens, CA
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Hickory, North Carolina 28602
714
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Hickory, NC
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Houston, Texas 77030
1605
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Houston, TX
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Jacksonville, Florida 32207
1017
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Jacksonville, FL
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Kissimmee, Florida 34744
1130
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
236
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Lawrenceville, NJ
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Lexington, Kentucky 40503
768
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Lexington, KY
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Los Angeles, California 90027
2588
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Los Angeles, CA
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Louisville, Kentucky 40213
821
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Minneapolis, Minnesota 55404
1118
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Minneapolis, MN
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Mission Hills, California 91345
2593
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Mission Hills, CA
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Mount Pleasant, South Carolina 29464
815
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Nashville, Tennessee 37203
940
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Olive Branch, Mississippi 38654
1128
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Olive Branch, MS
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Olympia, Washington 98502
2517
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Roswell, Georgia 30076
917
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Saint George, Utah 84790
2262
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Saint George, UT
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Saint Petersburg, Florida 33713
1199
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Saint Petersburg, FL
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Salisbury, North Carolina 28144
682
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Shavano Park, Texas 78231
1759
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Spring Valley, California 91978
2597
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Springfield, Illinois 62702
977
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Tampa, Florida 33612
1175
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Tarzana, California 91356
2600
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Topeka, Kansas 66606
1302
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Wadsworth, Ohio 44281
555
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Wilmington, North Carolina 28401
673
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Winchester, Virginia 22601
429
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Winchester, VA
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