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

Novo Nordisk

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Standard of care; Drug: Semaglutide

Study type: Interventional

Funder types: Industry

Identifiers

NCT03596450

U1111-1207-6474 (Other Identifier)

NN9535-4416

Details and patient eligibility

About

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.

Enrollment: 1,278 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 the 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,278 participants in 2 patient groups

Semaglutide

Experimental group

Description:

Participants will receive semaglutide subcutaneously (s.c.) in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

Treatment:

Drug: Semaglutide

Standard of care

Active Comparator group

Description:

Participants will receive standard of care in addition to metformin monotherapy as treatment intensification in the course of routine clinical practice. Participants will be followed for 2 years, regardless of changes in antidiabetic treatment over the course of the study.

Treatment:

Drug: Standard of care