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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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
IcoSema
insulin icodec
semaglutide
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Sequence 1

Sequence 2

Sequence 3

Sequence 4

Sequence 5

Sequence 6

Arm Description

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.

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.

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours*pmol/L
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

Secondary Outcome Measures

AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose
Measured in hours*pmol/L
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose
Measured in pmol/L
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose
Measured in hours
t1/2,Ico: Terminal half-life for insulin icodec after a single dose
Measured in hours
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
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose
Measured in (nmol/L)/mg
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose
Measured in hours
t1/2,Sema: Terminal half-life for semaglutide after a single dose
Measured in hours
Adverse events
Number of events

Full Information

First Posted
June 23, 2022
Last Updated
August 21, 2023
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT05435677
Brief Title
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
Official 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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
June 22, 2022 (Actual)
Primary Completion Date
April 25, 2023 (Actual)
Study Completion Date
April 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sequence 1
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 2
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 3
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 4
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 5
Arm Type
Experimental
Arm Description
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.
Arm Title
Sequence 6
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
IcoSema
Intervention Description
One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
Intervention Type
Drug
Intervention Name(s)
insulin icodec
Intervention Description
One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
Intervention Type
Drug
Intervention Name(s)
semaglutide
Intervention Description
One single dose of semaglutide administered subcutaneously, S.c. into the left thigh
Primary Outcome Measure Information:
Title
AUCIco,0-tz:Area under the serum insulin icodec concentration-time curve after a single dose
Description
Measured in hours*pmol/L
Time Frame
From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Title
Dose-normalised AUCSema,0-tz: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Description
Measured in (hours*nmol/L)/mg
Time Frame
From 0 hours to tz hours after IMP administration (day 1) where tz is the time of the last quantifiable concentration
Secondary Outcome Measure Information:
Title
AUCIco,0-inf: Area under the serum insulin icodec concentration-time curve after a single dose
Description
Measured in hours*pmol/L
Time Frame
From 0 hours to infinity after IMP administration (day 1)
Title
Cmax,Ico: Maximum observed serum insulin icodec concentration after a single dose
Description
Measured in pmol/L
Time Frame
From 0 hours until last measurement time after IMP administration (day 1)
Title
tmax,Ico: Time to maximum observed serum insulin icodec concentration after a single dose
Description
Measured in hours
Time Frame
From 0 hours until last measurement time after IMP administration (day 1)
Title
t1/2,Ico: Terminal half-life for insulin icodec after a single dose
Description
Measured in hours
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)
Title
Dose-normalised AUCSema,0-inf: Area under the plasma semaglutide concentration-time curve after a single dose divided by dose
Description
Measured in (hours*nmol/L)/mg
Time Frame
From 0 hours to infinity after IMP administration (day 1)
Title
Dose-normalised Cmax,Sema: Maximum observed plasma semaglutide concentration after a single dose divided by dose
Description
Measured in (nmol/L)/mg
Time Frame
From 0 hours until last measurement time after IMP administration (day 1)
Title
tmax,Sema: Time to maximum observed plasma semaglutide concentration after a single dose
Description
Measured in hours
Time Frame
From 0 hours until last measurement time after IMP administration (day 1)
Title
t1/2,Sema: Terminal half-life for semaglutide after a single dose
Description
Measured in hours
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)
Title
Adverse events
Description
Number of events
Time Frame
From IMP administration (day 1) to end of follow-up for each treatment period (day 36)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Transparency (dept. 2834)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100089
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
"According to the Novo Nordisk disclosure commitment on novonordisk-trials.com"
IPD Sharing URL
http://novonordisk-trials.com

Learn more about this trial

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

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