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

  • End date
    Mar 15, 2023
  • participants needed
  • sponsor
    Novo Nordisk A/S
Updated on 26 January 2021
Novo Nordisk
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Novo Nordisk Investigational Site (2.2 mi away) Contact
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drug test
antidiabetic agents


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.

Condition NIDDM, Diabetes Mellitus, Type 2, Diabetes Mellitus Type 2, type 2 diabetes mellitus, type 2 diabetes, type ii diabetes, noninsulin-dependent diabetes mellitus, diabetes type 2
Treatment Standard of Care, semaglutide
Clinical Study IdentifierNCT03596450
SponsorNovo Nordisk A/S
Last Modified on26 January 2021


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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 18 years or older at the time of
signing informed consent. - Type 2 diabetes mellitus diagnosis.- Treatment
with either 1 or 2 oral antidiabetic medications
Current member of a commercial or Medicare health plan with pharmacy benefits.- Recorded HbAlc 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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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