Diabetes Mellitus, Type 2 MedDRA version: 21.1 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. 2. Diagnosed with type 2 diabetes mellitus equal to or more than 180days 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. Treated with once daily or twice daily basal insulin analogue (insulin degludec, insulin detemir, insulin glargine U100 or U300, total daily dose of 10-50 U, both inclusive) equal to or more than 90 days prior to the day of screening. 5. 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 ) 6. Body mass index (BMI) equal to or below 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 75 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 75
Exclusion criteria
Exclusion criteria: 1. Known or suspected hypersensitivity to trial product(s) or related products. 2. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. 3. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 90 days before screening. 4. 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. 5. Any episodes of diabetic ketoacidosis within the past 90 days prior to the day of screening and between screening and randomisation. 6. Known hypoglycaemic unawareness as indicated by the Investigator according to Clarke’s questionnaire question 8. 7. Recurrent severe hypoglycaemic episodes within the last year as judged by the Investigator. 8. 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect on glycaemic control of treatment with once weekly insulin 287 using two different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4i ± SGLT2i in basal insulin analogue treated T2DM subjects ;Secondary Objective: To compare the safety and tolerability of once weekly insulin 287 using 2 different switch approaches versus once daily insulin glargine U100 both in combination with metformin ± DPP4i ± SGLT2i in basal insulin analogue treated 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
Canada, European Union, Germany, United States
Contacts
Public ContactClinical Disclosure (1452)
Novo Nordisk A/S
Outcome results
None listed