A Research Study to Look at How Insulin Icodec and Semaglutide Work in the Body of People From China With Type 2 Diabetes When Given Alone or Together

A Study Investigating the Pharmacokinetic Properties of a Single Dose of IcoSema Compared With Insulin Icodec and Semaglutide Given Separately in Chinese Participants With Type 2 Diabetes

This study will look at a new medicine, called IcoSema, for treatment of type 2 diabetes.

IcoSema is a combination of a new insulin, called insulin icodec, and a GLP-1 receptor analogue, called semaglutide.

Insulin icodec is a possible new medicine. That means that the medicine has not yet been approved by the authorities. Semaglutide is a medicine already approved by the authorities in the EU, USA, China and Japan.

The study will look at the way insulin icodec and semaglutide reach and stay in participants blood after injection when given together as IcoSema or alone as insulin icodec and semaglutide.

Participants will get each of the 3 medicines (IcoSema, insulin icodec and semaglutide) at 3 different timepoints:

The order in which participants get them is decided by chance. Participants will get the 3 medicines as an injection under the skin in the thigh. The injections will be done by study staff. The time between injections is 6 to 9 weeks.

The study will last for about 19 to 26 weeks. Participants will have 31 or 32 visits to the clinic. 3 of the visits will be in-house visits, meaning that participants will stay at the clinic for 5 or 6 days (4 or 5 nights).

Women cannot take part if pregnant, breast-feeding or plan to get pregnant during the study period.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: IcoSema; Drug: insulin icodec; Drug: semaglutide

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100089
      • Peking University Third Hospital, Northern branch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 62 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Chinese male or female
• Aged 18-64 years (both inclusive) at the time of signing informed consent
• Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
• Body mass index between 18.5 and 34.9 kg/m^2 (both inclusive)
• Body weight greater than or equal to 50 kg
• HbA1c (glycated haemoglobin) below or equal to 9.0% (75 mmol/mol)
• 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) including any of the following anti-diabetic drug(s)/regimen within 45 days prior to the day of screening:

  • Any metformin formulation
  • DPP-4 (dipeptidyl peptidase-4) inhibitors (participants are not allowed to participate in the study if they are treated with DPP-4 inhibitors as monotherapy)
  • SGLT2 (sodium-glucose linked transporter 2) inhibitors
  • Alpha-glucosidase inhibitors
  • Oral combination products (for the allowed individual oral antidiabetic drugs)

Exclusion Criteria:

• Known or suspected hypersensitivity to trial product(s) or related products
• Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using highly effective contraceptive method
• Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within 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
• Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event within the past 180 days) or hypoglycaemic unawareness as judged by the investigator or hospitalisation for diabetic ketoacidosis within the past 180 days prior to the day of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sequence 1; All participants will get each of the 3 medicines at 3 different timepoints IcoSema - insulin icodec - semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Experimental: Sequence 2; All participants will get each of the 3 medicines at 3 different timepoints IcoSema- semaglutide . insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Experimental: Sequence 3; All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- IcoSema- semaglutide, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Experimental: Sequence 4; All participants will get each of the 3 medicines at 3 different timepoints insulin icodec- semaglutide - IcoSema separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Experimental: Sequence 5; All participants will get each of the 3 medicines at 3 different timepoints semaglutide - IcoSema - insulin icodec, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Experimental: Sequence 6; All participants will get each of the 3 medicines at 3 different timepoints semaglutide - insulin icodec - IcoSema, separated by a 1-4-week wash-out period. The study will last for about 19 to 26 weeks.	Drug: IcoSema; One single dose of IcoSema administered subcutaneously, S.c. into the left thigh; Drug: insulin icodec; One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh; Drug: semaglutide; One single dose of semaglutide administered subcutaneously, S.c. into the left thigh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose	Measured in hours*pmol/L	From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose	Measured in (hours*nmol/L)/mg	From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose	Measured in hours*pmol/L	From 0 hours to infinity after IMP administration (day 1)
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose	Measured in pmol/L	From 0 hours until last measurement time after IMP administration (day 1)
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose	Measured in hours	From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Ico: Terminal half-life for insulin icodec after a single dose	Measured in hours	Terminal part of the serum insulin icodec concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose	Measured in (hours*nmol/L)/mg	From 0 hours to infinity after IMP administration (day 1)
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose	Measured in (nmol/L)/mg	From 0 hours until last measurement time after IMP administration (day 1)
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose	Measured in hours	From 0 hours until last measurement time after IMP administration (day 1)
t1/2,Sema: Terminal half-life for semaglutide after a single dose	Measured in hours	Terminal part of the plasma semaglutide concentration-time curve where the curve is well approximated by a straight line on logarithmic scale after IMP administration (day 1)
Adverse events	Number of events	From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2022
• Primary Completion (Actual): April 25, 2023
• Study Completion (Actual): April 25, 2023

Study Registration Dates

• First Submitted: June 23, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (Actual): June 28, 2022

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Glucagon-Like Peptide-1 Receptor Agonists; Semaglutide
• Other Study ID Numbers: NN1535-4710; U1111-1262-1959 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: "According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No