A research study to compare a new weekly insulin, insulin icodec used with DoseGuide App, and daily insulins in people with type 2 diabetes who have not used insulin before
- 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
- EUCTR2020-000476-38-PL
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1096
- Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
- Male or female age 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.
- Glycosylated haemoglobin (HbA1c) above 7.0% (53 mmol/mol) as measured by central lab.
- 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.
- Stable daily dose(s) 90 days or more prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s):
a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose.
b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose.
c. Any of the following non-insulin antidiabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose):
i. Sulfonylureas
ii. Meglitinides (glinides)
iii. Dipeptidyl peptidase 4 (DPP-4) inhibitors
iv. Sodium-glucose cotransporter-2 (SGLT2) inhibitors
v. Thiazolidinediones
vi. Alpha-glucosidase inhibitors
vii. Oral combination products (for the allowed individual Oral Antidiabetic
Drugs (OADs))
viii. Oral or injectable glucagon-like protein-1 (GLP-1)-receptor agonists
8. Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.
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 713
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 383
- Known or suspected hypersensitivity to trial product(s) or related products.
- Previous participation in this trial. Participation is defined as signed informed consent.
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or nonapproved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has
been received more than 30 days before screening).
- Any disorder which in the investigator’s opinion might jeopardise subject’s safety.
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 effectiveness on glycaemic control of once weekly insulin icodec used with DoseGuide in combination with non-insulin anti-diabetic drugs in insulin naïve subjects with Type 2 diabetes (T2D) in a clinical practice setting. This includes comparing the difference in change from baseline in HbA1c between insulin icodec used with DoseGuide and once daily basal insulin analogues after 52 weeks of treatment to a non-inferiority limit of 0.3%.;Secondary Objective: To compare effect on safety and patient reported outcomes related to treatment satisfaction and compliance of once weekly insulin icodec used with DoseGuide versus once daily basal insulin analogues both in combination with any non-insulin antidiabetic drugs in insulin-naïve subjects with T2D in a clinical practice setting.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 52 (V6)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): 1. Time from baseline to treatment discontinuation or intensification<br>2. Change in DTSQs (Diabetes Treatment Satisfaction Questionnaire) in total treatment satisfaction<br>3. Trim-D (Treatment Related Impact Measure for Diabetes) compliance domain<br>4. Number of severe hypoglycaemic episodes (level 3) <br>5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by blood glucose (BG) meter) <br>6. 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);Timepoint(s) of evaluation of this end point: 1. - 2. From baseline week 0 (V2) to week 52 (V6)<br>3. At end of treatment week 52 (V6)<br>4. - 6. From baseline week 0 (V2) to week 57 (V8)