A research study to compare two types of insulin, a new weekly insulin, insulin icodec and an available daily insulin, insulin glargine, both in combination with mealtime insulin, in people with type 2 diabetes who use daily insulin and mealtime insuli
- Conditions
- Diabetes Mellitus, Type 2MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2020-000474-16-BE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 580
- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2D 180 days or more prior to the day of screening.
- HbA1c from 7.0-10.0% (53.0-85.8 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Treated with once daily basal insulin (neutral protamine hagedorn insulin, insulin degludec, insulin detemir, insulin glargine 100 units/mL, or insulin glargine 300 units/mL) and 2-4 daily injections of bolus insulin analog (insulin aspart, faster acting insulin aspart, insulin lispro, insulin glulisine) 90 days or more prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses 90 days or more prior to screening:
-Metformin
-Sulfonylureas
-Meglitinides (glinides)
-Dipeptidyl peptidase-4 (DPP-4) inhibitors
-Sodium-glucose Cotransporter-2 (SGLT2) inhibitors
-Thiazolidinediones
-Alpha-glucosidase inhibitors
-Oral combination products (for the allowed individual oral anti-diabetic drugs)
-Oral or injectable glucagon-like peptide-1 (GLP-1) receptor agonists
- 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 348
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 232
- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association Class IV at screening.
- 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 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To demonstrate the effect on glycaemic control of once weekly insulin icodec in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with type 2 diabetes (T2D) on a basal-bolus regimen. This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 26 weeks of treatment to a non-inferiority limit of 0.3%.;Secondary Objective: To compare safety with once weekly insulin icodec versus once daily insulin glargine, both in combination with insulin aspart, with or without non-insulin anti-diabetic drugs, in subjects with T2D on a basal-bolus regimen.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 26 (V28)
- Secondary Outcome Measures
Name Time Method