Diabetes Mellitus, Type 2 MedDRA version: 18.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 100000004861
Conditions
Interventions
Trade Name: Xultophy
Pharmaceutical Form: Solution for injection
INN or Proposed INN: INSULIN DEGLUDEC
CAS Number: 844439-96-9
Concentration unit: U/ml unit(s)/millilitre
Concentration type: equal
Con
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, age = 18 years at the time of signing informed consent 2. Subjects diagnosed (clinically) with type 2 diabetes mellitus 3. HbA1c 7.0-11.0% [53-97 mmol/mol] (both inclusive) by central laboratory analysis 4. Body mass index (BMI) = 20 kg/m^2 and =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1. Receipt of any investigational medicinal product within 90 days prior to screening 2. Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening 3. Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening 4. 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 5. Subjects presently classified as being in NYHA Class III or IV 6. Renal impairment estimated Glomerular Filtration Rate < 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) 7. Impaired liver function, defined as ALT = 2.5 times upper normal limit at screening 8. Known or suspected hypersensitivity to trial product(s) or related products
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm the effect of insulin degludec/liraglutide (IDegLira) in terms of glycaemic control in subjects with type 2 diabetes mellitus (T2DM) on previous treatment with sodium-glucose cotransporter 2 inhibitors (SGLT2i) ± oral anti-diabetic drug (OAD) therapy. This is done by comparing the difference in change from baseline in HbA1c after 26 weeks to a non-inferiority margin of 0.3% for IDegLira versus insulin glargine (IGlar), both in combination with SGLT2i ± OAD.;Secondary Objective: To confirm superiority of IDegLira versus IGlar after 26 weeks in subjects with T2DM on previous treatment with SGLT2i ± OAD therapy in terms of one or more of the following: 1. Weight change 2. Treatment-emergent hypoglycaemic episodes (severe or blood glucose [BG] confirmed symptomatic) 3. Glycaemic control 4. Insulin dose To compare the effect and safety of IDegLira versus IGlar after 26 weeks ;Primary end point(s): Change from baseline in HbA1c ;Timepoint(s) of evaluation of this end point: After 26 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change from baseline in body weight 2. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes 3. Insulin dose, total daily dose (U) 4. Responder (Yes/No) for HbA1c < 7.0% 5. Change from baseline in fasting plasma glucose (FPG) 6. Number of treatment-emergent adverse events ;Timepoint(s) of evaluation of this end point: 1. After 26 weeks 2. During 26 weeks 3. After 26 weeks 4. After 26 weeks 5. After 26 weeks 6. During 26 weeks | — |
Countries
Argentina, Canada, European Union, Finland, Hungary, India, Slovakia, Slovenia, Spain, Switzerland, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed