Health Condition 1: null- Type 2 Diabetes
Conditions
Interventions
Intervention1: Liraglutide
: Liraglutide will be initiated with a starting dose of 0.6 mg/day, with subsequent weekly
dose escalations of 0.6 mg/day in accordance with the approved dose escalation for
Sponsors
Novo Nordisk India Private Ltd
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. 3. Diagnosed with type 2 diabetes mellitus. 4. HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive). 5. Stable dose of an SGLT-2 inhibitor as monotherapy or in combination (including fixed-dose drug combination) with a stable dose of metformin (>= 1500 mg or maximum tolerated dose) for at least 90 days prior to the day of screening. All medications in compliance with current local label. 6. Body mass index greater than 20 kg/m2."
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 an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice).Brazil: According to resolution 466/12: Regarding exclusion criterion: Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice). For women who expressly declare free of the risk of pregnancy, either by not engaging in sexual activity or by having sexual activity with no birth potential risk, use of contraceptive method will not be mandatory. 4. Receipt of any investigational medicinal product within 90 days before screening. 5. 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 during the 90 days prior to the day of screening is allowed. 6. Any disorder which in the investigatorâ??s opinion might jeopardise subjectâ??s safety or compliance with the protocol. 7. History of diabetic ketoacidosis while being treated with SGLT2 inhibitors. 8. Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative. 9. History or presence of pancreatitis (acute or chronic). 10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of mL/min/1.73m2 as defined by KDIGO1 classification using isotope dilution mass spectrometry (IDMS) for serum creatinine measured at screening. 11. Impaired liver function, defined as ALT >=2.5 times upper normal limit at screening. 12. Subjects presently classified as being in New York Heart Association (NYHA) Class IV. 13. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening. 14. Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening. 15. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (systolic >=180 mmHg or diastolic >=110 mmHg) at screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin on glycaemic control in subjects with type 2 diabetes mellitus. Timepoint: Change from baseline to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin in subjects with type 2 diabetes mellitus with regards to: Body weight related parameters Selected cardiovascular risk factors SafetyTimepoint: Change from baseline to week 26 in body weight ;To compare the effect of liraglutide 1.8 mg/day versus placebo as add-on to an SGLT2 inhibitor ± metformin in subjects with type 2 diabetes mellitus with regards to: selected glucose metabolism parametersTimepoint: Change from baseline to week 26 in body weight | — |
Countries
Argentina, Brazil, Canada, India, Ireland, Italy, 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