Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Rybelsus
Pharmaceutical Form: Tablet
INN or Proposed INN: SEMAGLUTIDE
CAS Number: 910463-68-2
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 3-
Trade
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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). - Body Mass Index (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 *: 1. * Metformin (equal to or above 1500 mg or maximum tolerated or effective dose). 2. * Sulfonylureas (SU) (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose). 3. * Sodium-glucose co-transporter 2 (SGLT2) inhibitors (maximum tolerated dose). 4. Dipeptyl 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 terminate DPP-4 inhibitor treatment at randomisation (with no wash-out). Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1280 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 340
Exclusion criteria
Exclusion criteria: - Treatment with any medication for the indication 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm superiority of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily on glycated haemoglobin (HbA1c) reduction in subjects with type 2 diabetes (T2D) on stable dose of 1-3 oral anti-diabetic drugs (OADs).;Secondary Objective: 1. To confirm superiority of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily on body weight reduction in subjects with T2D on a stable dose of 1-3 OADs. 2. To compare the efficacy of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily on parameters related to glycaemic control in subjects with T2D on a stable dose of 1-3 OADs. 3. To compare the efficacy of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily on parameters related to weight-related outcomes in subjects with T2D on a stable dose of 1-3 OADs. 4. To compare the safety and tolerability of oral semaglutide 25 mg and 50 mg once daily versus oral semaglutide 14 mg once daily in subjects with T2D on stable dose of 1-3 OADs.;Primary end point(s): Change in glycated haemoglobin (HbA1c);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in body weight 2. Change in fasting plasma glucose (FPG) 3. Achievement of HbA1c below 7% (Yes/No) 4. Achievement of HbA1c equal to or below 6.5% (Yes/No) 5. Relative change in body weight 6. Change in waist circumference 7. Achievement of weight loss equal to or above 5% (Yes/No) 8. Achievement of weight loss equal to or above 10% (Yes/No) 9. Adverse events;Timepoint(s) of evaluation of this end point: 1. + 2. From baseline (week 0) to week 52 3. + 4. At week 52 5. + 6. From baseline (week 0) to week 52 7. + 8. At week 52 9. From baseline (week 0) to follow-up visit (week 73) | — |
Countries
Australia, Bulgaria, Canada, Croatia, Estonia, European Union, Germany, Hungary, India, Poland, Slovakia, Slovenia, Taiwan, United States
Contacts
Public ContactClinical Transparency (1452)
Novo Nordisk A/S
Outcome results
None listed