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

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ClinicalTrials.gov Identifier: NCT04582435
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : November 16, 2021
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Insulin Icodec Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Insulin Icodec in Subjects With Type 2 Diabetes
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : March 27, 2022
Estimated Study Completion Date : March 27, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin icodec
Participants will receive individualised weekly doses of insulin icodec
 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.


Outcome Measures
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Primary Outcome Measures :
  1. AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    pmol*h/L


Secondary Outcome Measures :
  1. AUCGIR,0-36h,SS,Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 0 to 36 hours after trial product administration (Day 36) ]
    mg/kg

  2. AUCGIR,40-64h,SS,Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 40 to 64 hours after trial product administration (Day 43) ]
    mg/kg

  3. AUCGIR,144-168h,SS,Area under the glucose infusion rate-time curve at steady state [ Time Frame: From 144 to 168 hours after trial product administration (Day 50) ]
    mg/kg

  4. AUCGIR,τ,SS,model, Model-based area under the glucose infusion rate-time curve during one dosing interval at steady state [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    mg/kg

  5. AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state [ Time Frame: From 0 to 168 hours after trial product administration (Day 36 and 43) ]
    pmol*h/L

  6. Dose-normalised AUCIco,τ,SS, Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    (pmol*h/L)/(U/kg)

  7. Cmax,Ico,SS, Maximum observed serum insulin icodec concentration during one dosing interval at steady state [ Time Frame: From 0 to 168 hours after trial product administration (Day 36, 43 and 50) ]
    pmol/L

  8. Dose-normalised Cmax,Ico,SS, Maximum observed serum insulin icodec concentration after the last dose divided by dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    (pmol/L)/(U/kg)

  9. tmax,Ico,SS, Time to maximum observed serum insulin icodec concentration after the last dose [ Time Frame: From 0 to 168 hours after trial product administration (Day 50) ]
    hours

  10. t½,Ico,SS, Terminal half-life for insulin icodec at steady state [ 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 last trial product administration (Day 50) ]
    hours


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04582435


Contacts
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Contact: Novo Nordisk (+1) 866-867-7178 clinicaltrials@novonordisk.com

Locations
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Austria
Novo Nordisk Investigational Site Recruiting
Graz, Austria, 8010
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Transparency (dept. 1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT04582435    
Other Study ID Numbers: NN1436-4569
U1111-1244-4346 ( Other Identifier: World Health Organization (WHO) )
2019-004606-10 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: November 16, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs