Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin degludec / Liraglutide
: Dose: IDegLira (Minimum 10 dose step: 10 units of Insulin Degludec & 0.36mg of Liraglutide and Maximum prescribed is 50 dose step: 50 units of Insulin D
Sponsors
Novo Nordisk Pvt 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. Subjects diagnosed (clinically) with type 2 diabetes mellitus prior to the day of screening 4. HbA1c 7.0â??11.0% (both inclusive) (53â??97 mmol/mol) by central laboratory analysis 5. Body mass index (BMI) >= 20 kg/m2 6. Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes 7. Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: ï?· Biguanides (metformin >= 1500 mg or maximum tolerated dose documented in the subject medical record) ï?· Other OAD(s) allowed: sulphonylurea, glinides, pioglitazone, and DPP4-inhibitors (>= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record)"
Exclusion criteria
Exclusion criteria: "1. Known or suspected hypersensitivity to trial products or related products 2. Previous participation in this trial. Participation is defined as signed informed consent. Rescreening is not allowed 3. Female who is pregnant, breast-feeding or intend to become pregnant or of child-bearing potential 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 prior to screening Brazil: Participation in other trials within 1 year prior to screening visit (visit 1) unless there is a direct benefit to the research subject at the investigatorâ??s discretion. 5. Any disorder which in the opinion of the investigator might jeopardise subjectâ??s safety or compliance with the protocol 6. Screening calcitonin >= 50 ng/L 7. Renal impairment estimated Glomerular Filtration Rate (eGFR) 60 ml/min/1.73 m2 as per CKD-EPI value to be defined as listed in the classification CKD-EPI using IDMS for serum creatinine measurement on the day of screening11 8. Impaired liver function, defined as ALAT or ASAT >= 2.5 times upper limit of normal 9. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) in the previous 90 days prior to the day of the screening 10. Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroids Carcinoma 11. History of pancreatitis (acute or chronic) 12. 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 13. Subjects presently classified as being in NYHA Class IV 14. Planned coronary, carotid or peripheral artery revascularisation"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare long-term glycaemic control of IDegLira versus IGlar in insulin naïve subjects with T2DM inadequately controlled with OAD(s). Timepoint: 104 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare long-term efficacy and safety of IDegLira in insulin naïve subjects with T2DM inadequately controlled with OAD(s). Timepoint: 104 weeks | — |
Countries
Argentina, Brazil, Czech Republic, Hungary, India, Israel, Italy, Mexico, Norway, Poland, Russian Federation, Slovakia, South Africa, Turkey, United Kingdom, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Pvt Ltd.
Outcome results
None listed