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
Bristol, Tennessee 37620
2015
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Bristol, TN
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?
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Algiers,
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Anderson, South Carolina 29621
2008
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Anderson, SC
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Atlanta, Georgia 30318
1919
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Atlanta, GA
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Austin, Texas 78731
1212
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Austin, TX
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Butte, Montana 59701
872
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Butte, MT
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Chapel Hill, North Carolina 27599
2194
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Chapel Hill, NC
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Chicago, Illinois 60612
1728
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from 91732
Chicago, IL
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Clearwater, Florida 33756
2117
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from 91732
Clearwater, FL
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Concord, California 94520
353
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Concord, CA
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Dallas, Texas 75231
1225
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from 91732
Dallas, TX
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Des Moines, Iowa 50314
1422
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from 91732
Des Moines, IA
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Fresno, California 93702
209
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Fresno, CA
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Golden, Colorado 80401
807
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Golden, CO
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Greensboro, North Carolina 27408
2151
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Greensboro, NC
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Greenville, North Carolina 27834
2290
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Greenville, NC
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Hawaiian Gardens, California 90716
17
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Hawaiian Gardens, CA
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Hickory, North Carolina 28602
2069
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Hickory, NC
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Houston, Texas 77030
1357
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Houston, TX
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Jacksonville, Florida 32207
2131
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Jacksonville, FL
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Kissimmee, Florida 34744
2188
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Kissimmee, FL
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Lawrenceville, New Jersey 08648
2396
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Lawrenceville, NJ
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Lexington, Kentucky 40503
1879
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Lexington, KY
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Lomita, California 90717
25
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Lomita, CA
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Los Angeles, California 90027
16
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Los Angeles, CA
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Louisville, Kentucky 40213
1815
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Louisville, KY
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Minneapolis, Minnesota 55404
1509
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Minneapolis, MN
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Mission Hills, California 91345
28
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Mission Hills, CA
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Mount Pleasant, South Carolina 29464
2188
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Mount Pleasant, SC
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Nashville, Tennessee 37203
1762
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Nashville, TN
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Olive Branch, Mississippi 38654
1600
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Olive Branch, MS
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Olympia, Washington 98502
931
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Olympia, WA
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Roswell, Georgia 30076
1918
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Roswell, GA
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Saint George, Utah 84790
325
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Saint George, UT
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Saint Petersburg, Florida 33713
2128
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Saint Petersburg, FL
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Salisbury, North Carolina 28144
2117
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Salisbury, NC
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Shavano Park, Texas 78231
1181
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Shavano Park, TX
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Spring Valley, California 91978
324
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Spring Valley, CA
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Springfield, Illinois 62702
1610
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Springfield, IL
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Tampa, Florida 33612
2134
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Tampa, FL
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Tarzana, California 91356
31
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Tarzana, CA
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Topeka, Kansas 66606
1282
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Topeka, KS
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Wadsworth, Ohio 44281
2029
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Wadsworth, OH
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Wilmington, North Carolina 28401
2275
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Wilmington, NC
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Winchester, Virginia 22601
2219
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Winchester, VA
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