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

Conditions

• Diabetes Mellitus, Type 2

Eligibility Criteria

Sex

ALL

Age

18 Years - 65 Years

Healthy Volunteers

Not accepted

Interventions

• Semaglutide — DRUG
  Participants will be prescribed commercially available semaglutide s.c. and will be instructed to initiate treatment with semaglutide s.c. according to the approved label. The study doctor will determine the intended maintenance dose of semaglutide, as well as changes to the maintenance dose thereafter.
• Standard of care — DRUG
  Participants will receive standard of care, defined as commercially available oral or injectable antidiabetic medication other than semaglutide. Participants will be prescribed and instructed to initiate commercially available antidiabetic medication according to the approved label and, if relevant for the specific antidiabetic medication, adjusted at the discretion of the study doctor.

Study Details

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 Dates

Start date

Jul 13, 2018

Status verified

Jun 2024

Primary completion

Jun 9, 2022

Completion

Jun 9, 2023

Study Design

Enrollment

1,278 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Semaglutide
  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.
• Active Comparator: Standard of care
  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.

Primary Outcome Measure

Number of Participants With Glycosylated Haemoglobin (HbA1c) Less Than 7.0 Percentage (%) (53 Millimoles Per Mole [mmol/Mol]) at Year 1 (Yes/No) [ Time Frame: At year 1 ]

Locations (121)

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