Diabetes Mellitus, Type 2 MedDRA version: 19.0 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
Concentra
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 - Subjects diagnosed with type 2 diabetes mellitus - HbA1c 7.0-11.0% (both inclusive) (53–97 mmol/mol) by central laboratory analysis - Body mass index =20 kg/m^2 - 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 - Stable daily dose(s) including any of the following antidiabetic drug(s)/regimens within 90 days prior to the day of screening: o Biguanides (metformin =1500 mg or maximum tolerated dose documented in the subject medical record) o 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 subjects medical record) 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 900 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Screening calcitonin =50 ng/L - 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 screening - Impaired liver function, defined as ALAT or ASAT =2.5 times upper limit of normal - Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma - History of pancreatitis (acute or chronic) - 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 - Anticipated initiation or change in concomitant medications for more than 14 consecutive days or on a frequent basis known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus (T2DM) inadequately controlled on oral antidiabetic drugs (OAD[s]).;Secondary Objective: To compare long-term efficacy and safety of IDegLira versus IGlar in insulin naïve subjects with T2DM inadequately controlled with OAD(s).;Primary end point(s): Time from randomisation to inadequate glycaemic control and need for treatment intensification, defined as a glycosylated haemoglobin (HbA1c) of = 7.0% at 2 consecutive visits from week 26, including week 26 if HbA1c was = 7% at week 12.;Timepoint(s) of evaluation of this end point: Will be assessed up to 104 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Key supportive secondary efficacy endpoints: 1. Time from randomisation to an HbA1c > 6.5% at 2 consecutive visits 2. Change from baseline in: o HbA1c o body weight o Fasting plasma glucose (FPG) o 9-point Self-measured plasma glucose (SMPG) profile (individual points in the profile) 3. Insulin dose 4. Responder (yes/no): o HbA1c < 7.0% o HbA1c = 6.5% Key supportive secondary safety endpoints 5. Number of treatment-emergent severe or blood glucose confirmed symptomatic hypoglycaemic episodes ; Timepoint(s) of evaluation of this end point: 1. From week 26 2. After 26 weeks of treatment 3. After 26 weeks of treatment 4. After 26 and 104 weeks of treatment 5. During 26 and 104 weeks of treatment | — |
Countries
Argentina, Brazil, Czech Republic, European Union, Hungary, India, Israel, Mexico, Norway, Poland, Russian Federation, Slovakia, South Africa, Turkey, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed