Diabetes Mellitus, Type 2 MedDRA version: 17.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female, age =18 years at the time of signing informed consent - Type 2 diabetes subjects (diagnosed clinically) = 6 months prior to screening - HbA1c 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis - Current treatment with IGlar for at least 90 calendar days prior to screening - Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of ± 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive - Stable daily dose of metformin (=1500 mg or max. tolerated dose) for at least 90 calendar days prior to screening - Body mass index (BMI) = 40 kg/m^2 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 375 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 125
Exclusion criteria
Exclusion criteria: - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening - Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids) - Impaired liver function, defined as alanine aminotransferase (ALT) =2.5 times upper limit of normal - Renal impairment eGFR <60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Screening calcitonin =50 ng/L - History of pancreatitis (acute or chronic) - Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. To confirm superiority of IDegLira versus basal-bolus therapy in terms of: - number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment - change from baseline in body weight after 26 weeks of treatment 2. To compare general efficacy and safety of IDegLira versus basal-bolus therapy after 26 weeks of treatment. ;Main Objective: To confirm the efficacy of insulin degludec/liraglutide (IDegLira) in terms of glycaemic control in subjects with type 2 diabetes mellitus on previous treatment with insulin glargine (IGlar) and metformin. This is done by comparing the difference in change in HbA1c from baseline after 26 weeks of treatment to a non-inferiority limit of 0.30% for once daily IDegLira versus basal-bolus therapy with once daily IGlar plus prandial insulin aspart (IAsp), both arms in combination with metformin.;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Number of treatment emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes 2. Change from baseline in body weight 3. Responder for HbA1c (yes/no): - HbA1c < 7.0% - HbA1c = 6.5% ;Timepoint(s) of evaluation of this end point: 1. During 26 weeks of treatment 2. After 26 weeks of treatment 3. After 26 weeks of treatment | — |
Countries
Argentina, European Union, France, Greece, Hungary, Israel, Mexico, Russian Federation, Slovakia, Spain, Turkey, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed