Diabetes Mellitus, Type 2 MedDRA version: 20.1 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: 1. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. 2. Diagnosed with type 2 diabetes mellitus 180 days or longer prior to the day of screening. 3. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory. 4. Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s): a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose (as documented in subject’s medical records) b. Free or fixed combination therapy: Metformin as outlined above with or without DPP4i with or without SGLT2i is allowed: b. 1: DPP4i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose) b.2: SGLT2i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose ) 5. Insulin-naïve. 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. 6. Body mass index (BMI) equal to or above 40.0 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 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
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 an adequate contraceptive method. 4. Participation in any clinical trial, of an approved or non-approved investigational medicinal product within 90 days before screening. 5. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol. 6. Any episodes of diabetic ketoacidosis within the past 90 days, prior to the day of screening and between screening and randomisation. 7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation. 8. Presently classified as being in New York Heart Association (NYHA) Class IV. 9. Planned coronary, carotid or peripheral artery revascularisation between screening and randomisation. 10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012. 11. Impaired liver function, defined as Alanine Aminotransferase (ALT) equal to or above 2.5 times or Bilirubin above 1.5 times upper normal limit at screening. 12. Inadequately treated blood pressure, defined as Grade 3 hypertension or higher (Systolic equal to or above 180 mmHg or diastolic equal to or above 110 mmHg) at screening. 13. Treatment with any medication for the indication of diabetes, or obesity other than stated in the inclusion criteria within the past 90 days, prior to the day of screening. 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. 14. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination. 15. Presence or history of malignant neoplasms within 5 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 |
|---|---|
| Main Objective: To compare the effect on glycaemic control of once weekly insulin 287 using 3 different titration algorithms, versus once daily insulin glargine U100, both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects;Secondary Objective: To compare the safety and tolerability of once weekly insulin 287 using 3 different titration algorithms versus once daily insulin glargine U100 both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects;Primary end point(s): Time in target range 3.9–10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM);Timepoint(s) of evaluation of this end point: During the last 2 weeks of treatment (week 15 and 16) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in HbA1c 2. Change in fasting plasma glucose (FPG) 3. Change in body weight 4. Weekly insulin dose 5. Number of treatment emergent adverse events (TEAEs) 6. Number of severe hypoglycaemic episodes (level 3) 7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 8. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter);Timepoint(s) of evaluation of this end point: 1.-3. From baseline week 0 (V2) to week 16 (V18) 4. During the last 2 weeks of treatment (week 15 and 16) 5. From baseline week 0 (V2) to week 21 (V20) 6.-8. From baseline week 0 (V2) to week 16 (V18) | — |
Countries
Croatia, European Union, Germany, Hungary, Poland, Slovakia, Spain, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed