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

NCT05435677 | Completed Phase 1

• 2 other identifiers: NN1535-4710U1111-1262-1959
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (9)

• AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose

  From 0 hours to infinity after IMP administration (day 1)

• Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose

  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

  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

  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

  From 0 hours to infinity after IMP administration (day 1)

Study Arms (6)

Sequence 1

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Sequence 2

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Sequence 3

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Sequence 4

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Sequence 5

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Sequence 6

EXPERIMENTAL

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; Drug: insulin icodec; Drug: semaglutide

Interventions

IcoSema DRUG

One single dose of IcoSema administered subcutaneously, S.c. into the left thigh

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

insulin icodec DRUG

One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

semaglutide DRUG

One single dose of semaglutide administered subcutaneously, S.c. into the left thigh

Sequence 1; Sequence 2; Sequence 3; Sequence 4; Sequence 5; Sequence 6

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Peking University Third Hospital, Northern branch-Phase I

Beijing, Beijing Municipality, 100089, China

Location

Related Publications (1)

• Wang F, Luan Z, Maltesen R, Reenberg AT, Westergaard L, Liu D. Pharmacokinetic Characteristics of a Once-Weekly Combination Therapy of Insulin Icodec and Semaglutide Versus Its Separate Components in Chinese Individuals with Type 2 Diabetes. Diabetes Ther. 2025 Nov;16(11):2213-2225. doi: 10.1007/s13300-025-01803-x. Epub 2025 Oct 6.

  PMID: 41051695 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec; semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Transparency (dept. 2834)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Sponsor staff involved in the clinical trial is masked according to company standard procedures
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2022
• First Posted: June 28, 2022
• Study Start: June 22, 2022
• Primary Completion: April 25, 2023
• Study Completion: April 25, 2023
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)