Health Condition 1: null- Type 2 Diabetes Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Semaglutide
: 4 doses (4 weeks) of 0.25 mg, followed by 4 doses (4
weeks) of 0.5 mg and then maintenance
dose of semaglutide 1.0 mg/week for 44 doses (44weeks), Subcutaneous
Control In
Sponsors
Novo Nordisk India Private Ltd
Eligibility
Inclusion criteria
Inclusion criteria: a. 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. b.Male or female, age >=18 years at the time of signing informed consent. c.Diagnosed with type 2 diabetes mellitus (T2D). d.HbA1c of 7.0-10.5% (53-91 mmol/mol, both inclusive). e. Stable daily dose of metformin (>=1500 mg or maximum tolerated dose as documented in the subject medical record and in compliance with current local label) for at least 90 days prior to the day of screening.
Exclusion criteria
Exclusion criteria: a. Known or suspected hypersensitivity to trial product(s) or related products. b. Previous participation in this trial. c.Participation is defined as signed informed consent. d.Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). e.Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days prior to the day of screening. f.Any disorder which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol. Subject with alanine aminotransferase (ALT) >2.5 x upper normal limit (UNL). g.Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. h. History or presence of pancreatitis (acute or chronic). i.History of diabetic ketoacidosis (DKA). Any of the following: myocardial infarction (MI), stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. Subjects presently classified as being in New York Heart Association (NYHA) Class IV. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. j. Renal impairment measured as eGFR Improving global outcomes (KDIGO 2012)1 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening. k.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. l.Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within the past 90 days prior to randomisation. m.Presence or history of malignant neoplasms within the past 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed. n.Medical history of diabetes-related lower limb amputations or signs of critical lower limbischemia, (e.g. skin ulcer, osteomyelitis, or gangrene) within the last 26 weeks prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to week 52 in HbA1c Timepoint: week 0 to week 52 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline to week 52 in: - Fasting Plasma Glucose (FPG) - Systolic and diastolic blood pressure - Diabetes Treatment Satisfaction Questionnaire (DTSQ): Treatment satisfaction score (sum of 6 of 8 items) and the 8 items separately Timepoint: week 0 to week 52 | — |
Countries
Argentina, Brazil, Canada, India, Ireland, Lebanon, Malaysia, Mexico, Sweden, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed