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: - Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening. - HbA1c of 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory. - 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 greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject's medical record). b) Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose (as documented in subject medical record) with DPP4i (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose (as documented in subject's medical records). - 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. - Body mass index (BMI) less than or equal to 40.0 kg/sqm. 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 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: - Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation. - 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. - Presently classified as being in New York Heart Association (NYHA) Class IV. - 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. - 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). - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and randomisation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect on glycaemic control after 26 weeks treatment of once weekly insulin 287 versus once daily insulin glargine both in combination with metformin with or without dipeptidyl peptidase-4 inhibitors in insulin-naïve type 2 diabetes mellitus subjects inadequately treated with metformin with or without dipeptidyl peptidase-4 inhibitors.;Secondary Objective: To investigate the safety and tolerability during 26 weeks of treatment with once weekly insulin 287 versus once daily insulin glargine both in combination with metformin with or without dipeptidyl peptidase-4 inhibitors in insulin-naïve subjects with type 2 diabetes mellitus inadequately treated with metformin with or without dipeptidyl peptidase-4 inhibitors.;Primary end point(s): Change in glycated haemoglobin (HbA1c) (%-point and [mmol/mol]);Timepoint(s) of evaluation of this end point: From baseline (week 0) to week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in fasting plasma glucose (mmol/l) 2. Nine (9)-point profile (individual self-measured plasma glucose (SMPG) values) (mmol/l) 3. Change in mean of the 9-point profile, defined as the area under the profile (mmol/l) 4. Fluctuations of the 9-point profile (defined as the integrated absolute distance from the mean profile value divided by measurement time) (mmol/l) 5. Change in fasting C-peptide (mmol/l) 6. Change in body weight (kilogram) 7. Weekly dose of insulin 287 and weekly dose of IGlar (U) 8. Number of treatment emergent adverse events (TEAEs) 9. Number of hypoglycaemic alert episodes (level 1) (greater than or equal to 3.0 and less than 3.9 mmol/L (greater than or equal to 54 and less than70 mg/dL), confirmed by blood glucose (BG) meter) 10. Number of clinically significant hypoglycaemic episodes (level 2) (less than 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) 11. Number of severe hypoglycaemic episodes (level 3) 12. Change in anti-insulin 287 antibodies level 13. Change in anti-insulin 287 antibody titres 14. Change in cross-reactive anti-human insulin antibody status (positive/negative);Timepoint(s) of evaluation of this end point: 1, 3, 5 and 6: From baseline (week 0) to week 26 2 and 4: At week 26 7: Week 24-26 8 and 12-14: Baseline (week 0)-week 31 9 – 11: Baseline (week 0)-week 26 | — |
Countries
Canada, Czech Republic, European Union, Greece, Slovakia, Slovenia, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed