Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Trial



Status:Recruiting
Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Healthy:No
Age Range:18 - Any
Updated:3/21/2019
Start Date:July 13, 2018
End Date:November 19, 2021
Contact:Novo Nordisk
Email:clinicaltrials@novonordisk.com
Phone:(+1) 866-867-7178

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Long Term Comparative Effectiveness of Once Weekly Semaglutide Versus Standard of Care in a Real World Adult US Population With Type 2 Diabetes - a Randomized Pragmatic Clinical Trial

The main purpose of this study is to compare the effects of semaglutide (Ozempic®) with the
effects of other treatments for type 2 diabetes in a normal practice setting. The participant
will be assigned by chance (like flipping a coin) to one of the following treatment groups:
Group 1: semaglutide (Ozempic®) (by injection into skin) Group 2: standard of care
antidiabetic medication (oral or injectable). The participant has an equal chance of being in
either of the treatment groups. Neither the participant nor the study doctor or study staff
will be able to pick which group the participant is in, but the participant will know which
study drug the participant has been assigned to. The study doctor will provide the
participant with a prescription for the study diabetes medication based on the treatment
group the participant is assigned. The participation will last about 2 years.


Inclusion Criteria: - Informed consent obtained before any study-related activities.
Study-related activities are any procedures that are carried out as part of the study -
Male or female, age greater than or equal to 18 years at the time of signing informed
consent - Type 2 diabetes mellitus diagnosis - Treatment with metformin as antidiabetic
monotherapy - Current member of an Anthem affiliated commercial health plan - Recorded
Haemoglobin A1c value within last 90 days prior to randomization - Further intensification
with an additional antidiabetic oral or injectable medication is indicated to achieve
glycemic target at the discretion of the study physician according to approved labelling
Exclusion Criteria: - Previous randomization in this study - Treatment with any medication
for the indication of diabetes other than metformin in a period of 30 days before the day
of eligibility assessment. Temporary/emergency use of any type of insulin is allowed, as is
prior insulin treatment for gestational diabetes - Contraindications to semaglutide
according to the Food and Drug Administration approved label - Female who is pregnant,
breastfeeding or intends to become pregnant - Participation in another clinical trial
We found this trial at
29
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Albany, New York 12208
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Ashland, Kentucky 41101
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Atlanta, Georgia 30318
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Augusta, Georgia 30912
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Belfast, Maine 04915
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Chatham, Virginia 24531
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Colonial Heights, Virginia 23834
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Covington, Kentucky 41011
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Daleville, Virginia 23083
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Danville, Virginia 24541
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Falls Church, Virginia 22044
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Fort Wayne, Indiana 46805
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Garden Grove, California 92844
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Hamden, Connecticut 06518
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Lilburn, Georgia 30047
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Lynchburg, Virginia 24501
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Mason, OH
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Milford, Connecticut 06460
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Monterey, California 93940
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Owensboro, Kentucky 42303
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San Jose, California 95148
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Sandersville, Georgia 31082
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Savannah, Georgia 31406
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Statesboro, Georgia 30461
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Stockbridge, Georgia 30281
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Swainsboro, Georgia 30401
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Tulare, California 93274
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Warrenton, Virginia 20186
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