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

Completed · Phase 4

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID

NCT03596450

Run by

Novo Nordisk A/S

People needed

1278

Starts

2018-07-13

Expected to finish

2023-06-09

Last updated by the study team

2024-07-03

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Previous randomization in this study
• Treatment with more than 2 oral antidiabetic medications, oral semaglutide, or any injectable medication 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.

Where it is running

• St. Jos Heritage Hlthcr_Fllrtn — Fullerton, California, United States
• SC Clinical Research, Inc. — Garden Grove, California, United States
• New Hope Consulting & Clinical Trials — Lancaster, California, United States
• OM Research LLC — Lancaster, California, United States
• Pacific Clinical Studies — Los Alamitos, California, United States
• Pacific Medical Center — Milpitas, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Monterey Endocrine & Diabetes Institute, Inc — Monterey, California, United States
• Do-Eun Lee — Napa, California, United States
• Format Medical Research — Oxnard, California, United States
• Joselito C Cabaccan, MD — San Jose, California, United States
• Premier Medical Center, Inc. — Toluca Lake, California, United States
• Adnab Research/Prestige Care Physician — Torrance, California, United States
• Altura Centers For Health — Tulare, California, United States
• Tariq Javed, MD Inc. — Visalia, California, United States
• Endocrinology & Diabetes Specialists — Walnut Creek, California, United States
• University of Colorado Hospital — Denver, Colorado, United States
• Denver Endocrinology Diabetes and Thyroid Center — Englewood, Colorado, United States
• ProHealth Physicians/OptumCare — Bristol, Connecticut, United States
• Western Connecticut Health Network_Danbury — Danbury, Connecticut, United States
• Endocrine Associates of Connecticut — Hamden, Connecticut, United States
• Ismail Tarkhan MD — Milford, Connecticut, United States
• Steven L. Saunders MD LLC — Milford, Connecticut, United States
• The Kaufmann Clinic, Inc. — Atlanta, Georgia, United States
• American Clinical Trials — Buena Park, California, United States

Full record on ClinicalTrials.gov

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