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Novo Nordisk - SEPRA 9535-4416

Long term comparative effectiveness of once weekly semaglutide versus standard of care in a real-world adult US population with type 2 diabetes

Novo Nordisk - SEPRA 9535-4416
Benefits

Patient Benefits

Patients who screen and then enroll in the study will receive:

  • Study drug (active or comparator)
  • $30.00 per completed study visit for transport costs with a maximum benefit of $90 for the course of the study.

Study Duration

Study Duration for Patients

The total study duration is approximately 2 years. The number of visits required will depend on your regular standard of care, however, there are three required study visits.

Study Drug

Semaglutide

Semaglutide is a glucagon-like peptide-1 (GLP-1) analog

Eligibility

Inclusion Criteria

The following must be met in order to qualify for the study.

  •  Informed consent obtained before any study-related activities.
  • 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
  • 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

Patients with any of the following are ineligible to enroll in the study.

  • 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

** Other eligibility criteria exist to enroll in the study.   Study eligibility requirements are subject to change.  STAT Research and Dr. Wolfe reserve the right to exclude patients who do qualify for other reasons. Enrollment is limited and may be closed at anytime without prior notice.

Study Location

630 N. Main Street
Suite 210
Springboro, OH 45066

How to contact us...

1-833-STAT-833

See if you Qualify!

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Study Investigator

Dr. Joshua Ordway, M.D.
Dr. Joshua Ordway, M.D.

Principal Investigator

  • Dr. Ordway is a graduate of Princeton University and received his Doctorate from Wright State University Boonshoft School of Medicine. In his practice, he sees a variety of conditions and has a diverse background in treating conditions related to dermatology, rheumatology, geriatrics, joint injections, sports medicine, and multiple other therapeutic areas. In 2017, he joined STAT Research as a sub-investigator on multiple rheumatology studies and is now conducting his own studies as a Principal Investigator. His attention to detail coupled with passion for learning makes him a highly valued contributor to STAT Research and our continued effort to support the medical research industry.

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