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Completed

NCT Number: NCT05435677

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

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking University Third Hospital, Northern branch-Phase I

Beijing, Beijing Municipality, 100089, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IcoSema

Drug

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

Insulin icodec

Drug

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

semaglutide

Drug

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

Primary outcomes

  1. AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose

    Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

    Measured in hours*pmol/L

  2. Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose

    Time frame: From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration

    Measured in (hours*nmol/L)/mg

Secondary outcomes

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

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

    Measured in hours*pmol/L

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

    Time frame: From 0 hours until last measurement time after IMP administration (day 1)

    Measured in pmol/L

  3. tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose

    Time frame: From 0 hours until last measurement time after IMP administration (day 1)

    Measured in hours

  4. t1/2,Ico: Terminal half-life for insulin icodec after a single dose

    Time frame: 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)

    Measured in hours

  5. Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose

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

    Measured in (hours*nmol/L)/mg

  6. Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose

    Time frame: From 0 hours until last measurement time after IMP administration (day 1)

    Measured in (nmol/L)/mg

  7. tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose

    Time frame: From 0 hours until last measurement time after IMP administration (day 1)

    Measured in hours

  8. t1/2,Sema: Terminal half-life for semaglutide after a single dose

    Time frame: 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)

    Measured in hours

  9. Adverse events

    Time frame: From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

    Number of events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 28, 2022
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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