Diabetes Mellitus, Type 2 MedDRA version: 21.1 Level: LLT Classification code 10045242 Term: Type II diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Product Name: IcoSema 700 U/mL + 2 mg/mL PDS290
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: Insulin icodec
CAS Number: 1188379-43-2
Other descriptive name: Insul
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female and age above or equal to 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus 180 days or more before screening. - HbA1c of 7.0-10.0% (53.- 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening. - Treated with once daily or twice-daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) 20-80 units/day 90 days or more before screening. Short term bolus insulin treatment for a maximum of 14 days before screening is allowed, as is prior insulin treatment for gestational diabetes. The treatment can be with or without any of the following anti diabetic drugs with stable doses 90 days or more before screening: * Metformin * Sulfonylureas(a) * Meglitinides (glinides)(a) * DPP-4 inhibitors(a) * Sodium-glucose co-transporter 2 inhibitors * Alpha-glucosidase-inhibitors * Thiazolidinediones * Marketed oral combination products only including the products listed above. - Body mass index (BMI) less than or equal to 40.0 kg/m^2. (a) Sulfonylureas, meglitinides (glinides) and DPP-4 inhibitors must be discontinued at randomisation. 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 612 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method. - Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid, hormones, or systemic corticosteroids). - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. - Any episodes(a) of diabetic ketoacidosis within 90 days before screening. - Presence or history of pancreatitis (acute or chronic) within 180 days before screening. - Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening. - Chronic heart failure classified as being in New York Heart Association Class IV at screening. - Recurrent severe hypoglycaemic episodes within the last year (12 months) as judged by the investigator. - Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before 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. (a) as declared by the participant or in the medical records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To confirm non-inferiority of once weekly IcoSema compared with daily insulin glargine combined with insulin aspart, both treatment arms with or without OADs, in terms of glycaemic control measured by change in HbA1c from baseline after 52 weeks in participants with T2D inadequately controlled with daily basal insulin using a non-inferiority margin of 0.3%-point.;Secondary Objective: - To confirm superiority of once weekly IcoSema compared to daily insulin glargine combined with insulin aspart, both treatment arms with or without OADs, in participants with T2D inadequately controlled with daily basal insulin in terms of: •Change in body weight from baseline after 52 weeks •Number of clinically significant hypoglycaemic (level 2) or severe hypoglycaemic (level 3) episodes during 52 weeks and the 5 week follow up period •Weekly insulin dose (total) from week 50 to week 52 - To compare parameters of glycaemic control, patient reported outcomes and safety of once weekly IcoSema with daily insulin glargine combined with insulin aspart, both treatment arms with or without OADs, in participants with T2D inadequately controlled with daily basal insulin.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 52 (V54) | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 1. From baseline week 0 (V2) to week 52 (V54) 2. From baseline week 0 (V2) to week 57 (V56) 3. From week 50 (V52) to week 52 (V54) 4.-6. From week 48 (V50) to week 52 (V54) 7.-8. From baseline week 0 (V2) to week 52 (V54) 9.-10. From baseline week 0 (V2) to week 57 (V56);Secondary end point(s): 1. Change in body weight 2. Number of clinically significant hypoglycaemic episodes (level 2) ( 10.0 mmol/L (180 mg/dL)* 7. Change in fasting plasma glucose (FPG) 8. Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in total treatment satisfaction 9. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) 10. Number of severe hypoglycaemic episodes (level 3) * using continuous glucose monitoring (CGM) system, Dexcom G6 | — |
Countries
Czechia, Czech Republic, France, Germany, Hungary, India, Italy, Japan, Malaysia, Poland, Slovenia, South Africa, Thailand, Turkey, United States
Contacts
Public ContactClinical Transparency (2834)
Novo Nordisk A/S
Outcome results
None listed