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: Active, not recruiting
• Trial end date: 2023-05-15
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Hypoglycemic Agents

Criteria

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