A research study to see how a new weekly insulin, insulin icodec when given along with semaglutide helps in reducing the blood sugar level in patients with type 2 diabetes

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novo Nordisk A/S

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

9 Jan 2024 → 24 May 2025

Decision date (initial)

2023-08-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Novo Nordisk A/S

External identifiers

EU CT number

2022-502717-28-00

WHO UTN

U1111-1281-4752

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Therapy

To investigate the glycaemic control of intensification of insulin icodec with semaglutide in patients with T2D.

Secondary objectives 1

1. To investigate the safety of intensification of insulin icodec with semaglutide in patients with T2D.

Conditions and MedDRA coding

Diabetes Type 2

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Informed consent obtained before any study-related activities. Study‑related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Age above or equal to 18 years at the time of signing informed consent.
3. Diagnosed with type 2 diabetes (T2D) greater than or equal to (≥) 180 days prior to the day of screening.
4. Glycated haemoglobin (HbA1c) from 7.5 percent (%) ‑10.5 percent (%) (58‑91 millimoles/mole (mmol/mol)) (both inclusive) at screening confirmed by central laboratory analysis.
5. Treated with once daily or twice daily basal insulin (minimum of 0.25 International Units (IU)/Kilograms (kg)/day or 20 IU/day) without concomitant glucagon-like peptide-1 receptor agonists (GLP-1 RAs) ≥ 90 days prior to the day of screening with or without any of the following antidiabetic drugs/regimens with stable doses ≥ 90 days prior to screening: Metformin, Sulfonylureas, Meglitinides (glinides), Dipeptidyl peptidase-4 (DPP-4) inhibitors, Sodium-glucose co-transporter-2 (SGLT2 inhibitors), Thiazolidinediones,   Alpha-glucosidase inhibitors, Oral combination products (for the allowed individual oral anti-diabetic drugs)
6. Body mass index (BMI) less than or equal to (≤) 40.0 kg/m2 (square meters)
7. The need and willingness to undergo treatment intensification with the treatments investigated in this study with the aim to reach an HbA1c of 6.5% to 7.5% (48 mmol/mol to 58 mmol/mol) (both inclusive), as assessed by the investigator.
8. Ability and willingness to adhere to the protocol including performance of self-measured plasma glucose (SMPG) profiles according to the protocol.

Exclusion criteria 21

1. Known or suspected hypersensitivity to study intervention(s) or related products.
2. Previous participation in this study. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method, as defined in Appendix 4 (Section ‎10.4).
4. Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening. Note: Simultaneous participation in a study with the primary objective of evaluating an approved or non-approved 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 in the current study.
5. Any disorder, except for conditions associated with T2D, which in the investigator’s opinion might jeopardise participant’s safety or compliance with the protocol.
6. Any episodes of diabetic ketoacidosis within 90 days prior to the day of screening
7. Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
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 initiation.
9. Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
10. Planned coronary, carotid or peripheral artery revascularisation.
11. Renal impairment with estimated Glomerular Filtration Rate (eGFR) value of eGFR <30 mL/min/1.73m2.20
12. Impaired liver function, defined as Alanine Aminotransferase (ALT) ≥2.5 times or Bilirubin >1.5 times upper normal limit at screening.
13. Known hypoglycaemic unawareness as indicated by the investigator according to Clarke’s questionnaire question 821 (Section ‎8.2).
14. Recurrent severe hypoglycaemic episodes within the last year as judged by the investigator.
15. Inadequately treated blood pressure defined as systolic ≥180 millimetres of mercury (mmHg) or diastolic ≥110 mmHg at screening.
16. Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days prior to the day of screening.
17. 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).
18. 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 initiation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.
19. Presence or history of malignant neoplasms or in situ carcinomas (other than basal or squamous cell skin cancer, low-risk prostate cancer, or in-situ carcinomas of the cervix or carcinoma in situ/high grade prostatic intraepithelial neoplasia (PIN)) within 5 years before screening.
20. Use of any medication with unknown or unspecified content within 90 days before screening.
21. Personal or first-degree relative(s) history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 4

1. Change in glycated haemoglobin (HbA1c)
2. Change in mean 7-point SMPG profiles
3. Change in mean post‑prandial glucose increment (over all meals)
4. Change in fasting plasma glucose (FPG)

Secondary endpoints 5

1. Number of severe hypoglycaemic episodes (level 3)
2. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 milligrams Per Deciliter (mg/dL)), confirmed by blood glucose (BG) meter)
3. Number of clinically significant hypoglycaemic episodes (level 2) (<3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
4. Change in body weight
5. Relative change in weekly insulin icodec dose

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novo Nordisk A/S

Sponsor organisation

Novo Nordisk A/S

Address

Novo Alle 1

City

Bagsvaerd

Postcode

2880

Country

Denmark

Scientific contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission HUB

Public contact point

Organisation

Novo Nordisk A/S

Contact name

EU Submission HUB

Third parties 4

Locations

2 EU/EEA countries · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 30 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

8 submissions — initial application plus substantial / non-substantial modifications