Research Study to Compare Semaglutide Tablets With Empagliflozin Tablets Taken Once Daily in People With Type 2 Diabetes and Obesity

Study Overview
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Brief Summary
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This study compares the medicines semaglutide and empagliflozin in people with newly diagnosed type 2 diabetes and obesity. The study will look mainly at how well the blood sugar and body weight are controlled when participants are taking the study medicine. Participants will either get semaglutide tablets or empagliflozin tablets. Which treatment participants get is decided by chance. Participants will get one tablet per day for 2 years. The study will last for about 2 years and 8 weeks.

Official Title
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Efficacy and Safety of Early Initiation of Oral Semaglutide 50 mg Once Daily Versus Empagliflozin 25 mg Once Daily in Younger Patients With Newly Diagnosed Type 2 Diabetes and Obesity

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Semaglutide
* Drug: Empagliflozin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, age 18- less than (<) 50 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus less than or equal to (<=) 365 days from the day of screening. Glycated haemoglobin (HbA1c) of 7.0-9.5 percentage (%) (53-80 millimoles per milliliter [mmol/mol]) (both inclusive). Body mass index (BMI) greater than or equal to (>=) 30.0 kilograms per meter square (kg/m^2). Treatment naïve to any antidiabetic drug(s). However, for a subset of participants (≤25%) any metformin dose or formulations administered is allowed. Exclusion Criteria: Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria since diagnosed with type 2 diabetes mellitus. Prior insulin treatment for gestational diabetes is allowed. Renal impairment measured as estimated glomerular filtration rate (eGFR) value of less than (<) 60 milliliter per minute per 1.73 meter square (1.7mL/min/1.73 m^2) at screening. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to day of 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. C-peptide less than (<)1.5 nanograms per milliliter (ng/mL) at screening. Positive insulinoma associated-protein 2 (IA-2) antibodies or anti-glutamic acid decarboxylase (anti-GAD) antibodies. History of major surgical procedures involving the stomach or small intestine potentially affecting absorption of drugs and/or nutrients. Presence of clinically significant gastrointestinal disorders potentially affecting absorption of drugs and/or nutrients, as judged by the investigator.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral semaglutide<br>Participants will receive once daily oral semaglutide tablet for 104 weeks in a dose escalation fashion of 3milligrams (mg), 7mg, 14 mg and 25 mg once every four weeks during the first 16 weeks and a maintenance dose of 55 mg for the rest 88 weeks. | Drug: Semaglutide<br>* Participants will receive 1 tablet of oral semaglutide once daily.<br>|
| Active Comparator: Empagliflozin<br>Participants will receive once daily empagliflozin tablet for up to 104 weeks, starting with a dose of 10 mg for the first 8 weeks and the maintenance dose of 25 mg for the rest 96 weeks. | Drug: Empagliflozin<br>* Participants will receive 1 tablet of empagliflozin once daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants acheiving glycated haemoglobin (HbA1c) less than (<) 7 percentage (%) (Yes/No) | Measured as count of participants. | At week 104 | 
| Participants acheiving body weight reduction greater than or equal to (>=) 5% (Yes/No) | Measured as count of participants. | At week 104 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Triglycerides | Measured as ratio to baseline. | From randomisation (week 0) to week 104 | 
| Change in free fatty acids | Measured as ratio to baseline. | From randomisation (week 0) to week 104 | 
| Number of treatment emergent adverse events | Measured as count of events. | From randomisation (week 0) to week 109 | 
| Change in Control of Eating Questionnaire (CoEQ) score - Craving Control domain | Measured as score on a scale. Scales range from 0 (minimum) to 10 (maximum). | From randomisation (week 0) to week 104 | 
| Change in Control of Eating Questionnaire (CoEQ) score - Craving for Savory domaina | Measured as score on a scale. Scales range from 0 (minimum) to 10(maximum). | From randomisation (week 0) to week 104 | 
| Change in HbA1c | Measured as percentage (%)-point. | From randomisation (week 0) to week 104 | 
| Change in fasting plasma glucose (FPG) | Measured in millimoles per liter (mmol/l). | From randomisation (week 0) to week 104 | 
| Change in self-measured plasma glucose (SPMG) 7-point mean profile | Measured in millimoles per liter(mmol/l). | From randomisation (week 0) to week 104 | 
| Change in self-measured plasma glucose (SPMG) mean post prandial increments | Measured in millimoles per liter(mmol/l). | From randomisation (week 0) to week 104 | 
| Time to additional anti-diabetic medication | Measured in days. | From randomisation (week 0) to week 104 | 
| Change in body weight | Measured in kilograms (kg). | From randomisation (week 0) to week 104 | 
| Relative change in body weight | Measured as percentage (%). | From randomisation (week 0) to week 104 | 
| Change in waist circumference | Measured in centimeters (cm). | From randomisation (week 0) to week 104 | 
| Participants achieving glycated haemoglobin (HbA1c) less than or equal to (<=) 6.5% (Yes/No) | Measured as count of participants. | From randomisation (week 0) to week 104 | 
| Participants achieving glycated haemoglobin (HbA1c) reduction greater than or equal to (>=) 0.7%-point (Yes/No) | Measured as count of participants. | From randomisation (week 0) to week 104 | 
| Participants achieving body weight reduction greater than or equal to (>=) 5 percentage (%) | Measured as count of participants. | From randomisation (week 0) to week 104 | 
| Change in systolic blood pressure | Measured in millimiters of mercury (mmHg). | From randomisation (week 0) to week 104 | 
| Change in total cholesterol | Measured as ratio to baseline. | From randomisation (week 0) to week 104 | 
| Change in high density lipoprotein (HDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 | 
| Change in low density lipoprotein (LDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 | 
| Change in very low density lipoprotein (VLDL) | Measured as ratio to baseline. | From randomisation (week 0) to week 104 |