A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04582435
• Other study ID #: NN1436-4569
• Secondary ID: U1111-1244-43462
• Status: Completed
• Phase: Phase 1
• Start date: October 16, 2020
• Est. completion date: April 22, 2022

Study information

• Verified date: September 2023
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of the study is to improve clinical outcomes for patients with type 2 diabetes by limiting the burden associated with insulin treatment.

Participants will get insulin degludec as well as insulin icodec - Insulin icodec is a new medicine while insulin degludec is commonly used and prescribed by doctors.

Participants will administer subcutaneous injections of insulin degludec once daily for at least one week (7 injections) but this period may be extended up to 8 weeks. Thereafter, once weekly subcutaneous injections of insulin icodec will follow, resulting in a total of at least 8 but not more than 16 subcutaneous injections of icodec.

The study will last for about 17-32 weeks Participants will have at least 5 in-house visits (where participants will stay at the clinic) and 17 outpatient visits with the study doctor.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: April 22, 2022
• Est. primary completion date: April 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Male or female

• Aged 18-75 years (both inclusive) at the time of signing informed consent

• Body mass index between 18.0 and 38.0 kg/m^2 (both inclusive)

• HbA1c (glycated haemoglobin) below or equal to 9 percentage (75 mmol/mol) at screening

• Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 90 days prior to the day of screening: 1) Any metformin formulation 2) Other oral antidiabetic drugs: DPP-4 nhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)

• Oral or injectable GLP-1 Receptor Agonists

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 an adequate contraceptive method

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Insulin Icodec
Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.

Locations

Country	Name	City	State
Austria	Novo Nordisk Investigational Site	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Austria, 

References & Publications (1)

Pieber TR, Asong M, Fluhr G, Holler V, Kristensen NR, Larsen JH, Ribel-Madsen R, Svehlikova E, Vinther S, Voortman M, Haahr H. Pharmacokinetic and pharmacodynamic properties of once-weekly insulin icodec in individuals with type 2 diabetes. Diabetes Obes Metab. 2023 Sep 11. doi: 10.1111/dom.15266. Online ahead of print. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUCIco,t,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state	pmol*h/L	From 0 to 168 hours after trial product administration (Day 50)
Secondary	AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 0 to 36 hours after trial product administration (Day 36)
Secondary	AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 40 to 64 hours after trial product administration (Day 43)
Secondary	AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state	mg/kg	From 144 to 168 hours after trial product administration (Day 50)
Secondary	AUCGIR,t,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state	mg/kg	From 0 to 168 hours after trial product administration (Day 50)
Secondary	AUCIco,t,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state	pmol*h/L	From 0 to 168 hours after trial product administration (Day 36 and 43)
Secondary	Dose-normalised AUCIco,t,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose	(pmol*h/L)/(U/kg)	From 0 to 168 hours after trial product administration (Day 50)
Secondary	Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state	pmol/L	From 0 to 168 hours after trial product administration (Day 36, 43 and 50)
Secondary	Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose	(pmol/L)/(U/kg)	From 0 to 168 hours after trial product administration (Day 50)
Secondary	tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose	hours	From 0 to 168 hours after trial product administration (Day 50)
Secondary	t½,Ico,SS, Terminal half-life for insulin icodec at steady state	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 last trial product administration (Day 50)