A research study to compare two types of insulin, a new insulin, insulin icodec and an available insulin, insulin glargine, in people with type 2 diabetes who have not used insulin before

Phase 1

• Conditions: Diabetes Mellitus, Type 2; MedDRA version: 21.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 100000004861; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2020-000442-34-HR
• Lead Sponsor: ovo Nordisk A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-24
• Last Update Posted: 30 November 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 970

Inclusion Criteria

- 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 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- 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 anti-diabetic 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 oral anti-diabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
- Sulfonylureas
- Meglitinides (glinides)
- Dipeptidyl peptidase 4 (DPP-4) inhibitors
- Sodium-glucose Cotransporter-2 (SGLT2) inhibitors
- Thiazolidinedione
- Alpha-glucosidase inhibitor
- Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs))
- 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 960
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

- 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 (NYHA) 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 non-insulin anti-diabetic drugs, in insulin naïve subjects with type 2 diabetes (T2D). This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 52 weeks of treatment to a non-inferiority limit of 0.3%.;Secondary Objective: To compare parameters of glycaemic control and safety of once weekly insulin icodec with once daily insulin glargine, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with T2D.;Primary end point(s): Change in HbA1c;Timepoint(s) of evaluation of this end point: From baseline week 0 (V2) to week 52 (V46)