Status:
COMPLETED
Research Study to Compare Three Doses of Semaglutide Tablets Taken Once Daily in People With Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study compares three doses of once daily semaglutide tablets in people with type 2 diabetes who were previously treated with other oral anti-diabetic medicines. Participants will be initiated on ...
Eligibility Criteria
Inclusion
- Male or female, age above or equal to 18 years at the time of signing informed consent.
- Diagnosed with type 2 diabetes mellitus at least 180 days prior to the day of screening.
- HbA1c of 8.0-10.5% (64-91 mmol/mol) (both inclusive).
- BMI equal to or above 25 kg/m\^2
- Stable daily dose(s) for 90 days prior to the day of screening of any of the following treatment regimens:
- No more than 3 of the following oral anti-diabetic drugs and at least 1 marked with a \*:
- Metformin (equal to or above1500 mg or maximum tolerated or effective dose).
- Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
- Sodium/glucose cotransporter 2 (SGLT2) inhibitors (maximum tolerated dose).
- Dipeptidyl peptidase-4 (DPP-4) inhibitors (maximally indicated dose as per local label).
- Subjects, on treatment with stable dose of DPP-4 inhibitors at inclusion, must be willing to discontinue DPP-4 inhibitor treatment at randomisation (with no wash-out).
Exclusion
- Treatment with any medication indicated for the treatment of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed.
- Renal impairment measured as estimated glomerular filtration rate (eGFR) value of below 30 mL/min/1.73 m\^2 according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation as defined by kidney disease improving global outcomes (KDIGO 2012) classification.
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 8 2023
Estimated Enrollment :
1606 Patients enrolled
Trial Details
Trial ID
NCT04707469
Start Date
January 15 2021
End Date
March 8 2023
Last Update
December 9 2025
Active Locations (228)
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