Health Condition 1: null- Type 2 Diabetes Mellitus Health Condition 2: E11- Type 2 diabetes mellitus
Conditions
Interventions
Intervention1: Insulin Degludec / Insulin Aspart (Ryzodeg)
: 100 units/mL Solution for Subcutaneous injection, once daily for 26 weeks and will be adminstered twice daily post 26 weeks of treatment if
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 3. Diagnosed with type 2 diabetes mellitus 4. Treated with any basal insulin >= 90 days prior to the day of screening 5. Subject not on any OAD(s) prior to trial participation OR subjects on stable daily dose(s) of OAD(s) for at least 90 days prior to screening visit (V1). The OAD(s) include any of the following anti-diabetic drug(s)/regimen: a. Biguanides (metformin >= 1500 mg or maximum tolerated dose documented in the subject medical record) b. Other OADs (>= half of the maximum approved dose according to local label or maximum tolerated dose as documented in subject medical record): i. Insulin secretagogues (SU and glinides) ii. DPP-4 inhibitors iii. alpha glucosidase inhibitors iv. SGLT-2 inhibitors v. Oral combination products (of the allowed individual OADs) 6. HbA1c 7.0-10.0% (53-86 mmol/mol) (both inclusive) by central laboratory analysis 7. Body mass index (BMI) 8. Ability and willingness to adhere to the protocol including self-measurement of plasma glucose according to the protocol"
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. Participation in any clinical trial of an approved or non-approved investigationalmedicinal product within four weeks prior to the day of screening (V1) 5. Any chronic disorder or severe disease which, in the opinion of the investigator, might jeopardise subjectâ??s safety or compliance with the protocol 6. Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g. diabetes ketoacidosis) day of the screening 7. Any of the following: myocardial infarction, stroke or hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening and between screening and randomisation 8. Subjects presently classified as being in New York Heart Association (NYHA) Class IV 9. Planned coronary, carotid or peripheral artery revascularisation known on the day of screening 10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of ml/min/1.73 m2 as defined by KDIGO 2012 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 (UNL) at screening 12. Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic >=180 mmHg or diastolic >=110 mmHg) at screening 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 14. Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids) 15. Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 90 days prior to randomisation 16. Presence or history of malignant neoplasms within the past five years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed"
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in glycosylated haemoglobin (HbA1c) (%) Timepoint: week 0 to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| 9-point profileTimepoint: After 38 weeks;Change from baseline in fasting plasma glucose (FPG) after 38 weeksTimepoint: after 38 weeks;Change from baseline in HbA1c (%) after 38 weeks Timepoint: After 38 weeks;Mean pre-breakfast measurements used for titrationTimepoint: After 38 weeks;Post-prandial incrementsTimepoint: After 38 weeks;Responder (Yes/No) for HbA1c after 38 weeks: o HbA1c (less than 7% o HbA1c less than 7% without nocturnal (00:01-05:59) BG confirmed symptomatic hypoglycaemiaTimepoint: After 38 weeks;Self-measured plasma glucose measurements (SMPG) after 38 weeksTimepoint: after 38 weeks | — |
Countries
Algeria, Czech Republic, India, Russian Federation, Serbia, Turkey, United States of America
Contacts
Public ContactDr Anil N Shinde
Novo Nordisk India Private Ltd.
Outcome results
None listed