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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05435677
• Other study ID #: NN1535-4710
• Secondary ID: U1111-1262-1959
• Status: Completed
• Phase: Phase 1
• Start date: June 22, 2022
• Est. completion date: April 25, 2023

Study information

• Verified date: April 2024
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 25, 2023
• Est. primary completion date: April 25, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• IcoSema
One single dose of IcoSema administered subcutaneously, S.c. into the left thigh
• insulin icodec
One single dose of insulin icodec administered subcutaneously, S.c. into the left thigh
• semaglutide
One single dose of semaglutide administered subcutaneously, S.c. into the left thigh

Locations

Country	Name	City	State
China	Peking University Third Hospital, Northern branch	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Adverse events	Number of events	From IMP administration (day 1) to end of follow-up for each treatment period (day 36)