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

NCT04582435 | Completed Phase 1

• 3 other identifiers: NN1436-4569U1111-1244-43462019-004606-10
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• AUCIco,τ,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 Outcomes (10)

• AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state

  From 0 to 36 hours after trial product administration (Day 36)

• AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state

  From 40 to 64 hours after trial product administration (Day 43)

• AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state

  From 144 to 168 hours after trial product administration (Day 50)

• AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state

  From 0 to 168 hours after trial product administration (Day 50)

• AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state

  From 0 to 168 hours after trial product administration (Day 36 and 43)

Study Arms (1)

Insulin icodec

EXPERIMENTAL

Participants will receive individualised weekly doses of insulin icodec

Drug: Insulin Icodec

Interventions

Insulin Icodec DRUG

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.

Insulin icodec

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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 an adequate contraceptive method

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Graz, 8010, Austria

Location

Related 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 Dec;25(12):3716-3723. doi: 10.1111/dom.15266. Epub 2023 Sep 11.

  PMID: 37694740 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

insulin icodec

Condition Hierarchy (Ancestors)

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

Study Officials

• Clinical Transparency (dept. 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2020
• First Posted: October 9, 2020
• Study Start: October 16, 2020
• Primary Completion: April 22, 2022
• Study Completion: April 22, 2022
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share

Locations

AU (1)