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 |
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.
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
sites
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