Health Condition 1: null- Type 2 diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Oral Semaglutide
: Dose: 3mg, 7mg and 14 mg
Dose Form: Tablet
Frequency: Once Daily
Duration: 78 weeks
Control Intervention1: Sitagliptin
: Dose: 100 mg
Dose Form: Tablet
Frequency: Onc
Sponsors
Novo Nordisk AS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Male or female, age >= 18 years at the time of signing informed consent. For Japan only: Male or female, age >= 20 years at the time of signing informed consent. 3. Diagnosed with type 2 diabetes mellitus >= 90 days prior to day of screening. 4. HbA1c 7.0-10.5% (53-91 mmol/mol) (both inclusive). 5. Stable daily dose of metformin (>= 1500 mg or maximum tolerated dose as documented in the subject medical record) alone or in combination with SU (>= half of the maximum approved dose according to local label or maximum tolerated dose as documented in the subject medical record) within 90 days prior to the day of screening.
Exclusion criteria
Exclusion criteria: "1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Previous participation in this trial. Participation is defined as signed informed consent. 3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). 4.Receipt of any investigational medicinal product within 90 days before screening. 5. Any disorder, which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol. 6. Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN 2) or Medullary Thyroid Carcinoma (MTC). 7. History of pancreatitis (acute or chronic). 8. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g. subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery). 9. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischaemic attack within the past 180 days prior to the day of screening. 10. Subjects presently classified as being in New York Heart Association (NYHA) Class IV. 11. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 12. Renal impairment defined as estimated Glomerular Filtration Rate (eGFR) 60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). 13. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of 14. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation. 15. History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)."
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HbA1c values from baseline Timepoint: Week 0 to Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 26 in body weight (kg)Timepoint: week 0 to week 26;Change in HbA1c and Body weight (kg)Timepoint: From week 52 and to week 78;Change in:Body weight (%),FPG, SMPG, 7 point profile, Mean 7 point profile, Mean post prandial increment (over all meals), Body mass index (BMI),Waist circumference,Fasting lipid profile (total cholesterol, LDL cholesterol, VLDL cholesterol, HDL cholesterol, triglycerides, free fatty acids,Patient reported outcomes,Short Form-36 version 2 (SF-36v2â?¢) (acute version) health survey ,Impact of Weight on Quality of Life (IWQoL-Lite) Clinical Trial Version, Control of Eating questionnaire (CoEQ) Timepoint: from week 0 to week 26, to week 52 and to week 78;Subjects who after 26 weeks of treatment achieve(yes/no): HbA1c less than 7.0%(53 mmol/mol)ADA target,HbA1c â?¤ 6.5%(48 mmol/mol) American Association of Clinical Endocrinologists target, HbA1c reduction â?¥ 1%, Weight loss â?¥ 3 %, Weight loss â?¥ 5 %,Weight loss â?¥ 10%, HbA1c less than 7.0%(53 mmol/mol) without hypoglycaemia (treatment emergent severe or BG confirmed symptomatic hypoglycaemia) and no weight gain, HbA1c reduction â?¥ 1 % and weight loss â?¥ 3 % Timepoint: Week 0 to week 26 ,52 and 78 | — |
Countries
Argentina, Brazil, France, Germany, India, Israel, Japan, Mexico, Romania, Russian Federation, South Africa, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed