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
  • End date
    Mar 15, 2023
  • participants needed
    1387
  • sponsor
    Novo Nordisk A/S
Send
Updated on 25 November 2020
See if I qualify
drug test
semaglutide
antidiabetic agents

Summary

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.

Details
Treatment Standard of Care, semaglutide
Clinical Study IdentifierNCT03596450
SponsorNovo Nordisk A/S
Last Modified on25 November 2020

Adding a note
adding personal notes guide

Select a piece of text and start making personal notes.

Eligibility

 Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or NIDDM?
Do you have any of these conditions: noninsulin-dependent diabetes mellitus or diabetes type 2 or NIDDM or type ii diabetes or Diabetes Mellitus, Type 2 or type 2 diabetes or Diabetes Mel...?
Do you have any of these conditions: Diabetes Mellitus, Type 2 or Diabetes Mellitus Type 2 or diabetes type 2 or type 2 diabetes mellitus or type 2 diabetes or NIDDM or type ii diabetes o...?
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a site
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar
Name

Primary Contact

site
Name

Phone Email

0/250
Please verify that you are not a bot.
Step 2 Get screened

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more
Step 3 Enroll in the clinical study

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.

Learn more
Step 4 Get your study results

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

Learn more

Similar trials to consider

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study

user name
Edit Delete

Annotated by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No made yet