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A Study Looking at How Insulin Icodec is Taken up in the Blood When Administered in Different Injection Sites in People With Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT04582448
Recruitment Status : Recruiting
First Posted : October 9, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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Brief Summary:

This study is comparing the concentration of a single dose of insulin icodec when administered in the belly, upper arm and thigh on different occasions.

Participants will receive one injection of insulin icodec on three different occasions, each time injected at a different site, i.e. either on our belly, upper arm or thigh.

The study will last for about 34 weeks. Participants will have 23 visits with the study doctor. Informed Consent (V0) visit and screening visit (V1) will be performed on two different days. The informed consent visit may be performed via telephone to minimize personal contact with site staff during the coronavirus outbreak.

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 : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec After Administration in Different Injection Regions in Subjects With Type 2 Diabetes
Actual Study Start Date : October 16, 2020
Estimated Primary Completion Date : November 22, 2021
Estimated Study Completion Date : November 22, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin icodec treatment sequence with injection region abdomen
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
 Drug: Insulin icodec
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
Experimental: Insulin icodec treatment sequence with injection region upper arm
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
 Drug: Insulin icodec
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
Experimental: Insulin icodec treatment sequence with injection region thigh
Each subject will be randomised to one of six treatment sequences, consisting of three single-dose administrations of insulin icodec (s.c. in the abdomen, the upper arm and the thigh) in a balanced manner on three separate treatment visits.
 Drug: Insulin icodec
A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.


Outcome Measures
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Primary Outcome Measures :
  1. AUCIco,0-inf,SD, Area under the serum insulin icodec concentration-time curve after a single dose [ Time Frame: Day 1 ]
    From 0 hours until infinity after trial product administration (pmol*h/L)


Secondary Outcome Measures :
  1. Cmax,Ico,SD, Maximum observed serum insulin icodec concentration after a single dose [ Time Frame: Day 1 ]
    From 0 hours until infinity after trial product administration (pmol/L)

  2. tmax,Ico,SD, Time to maximum observed serum insulin icodec concentration after a single dose [ Time Frame: Day 1 ]
    From 0 hours until infinity after trial product administration (hours)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female
  • Aged 18-69 years (both inclusive) at the time of signing informed consent
  • Body mass index between 18.5 and 38.0 kg/m^2 (both inclusive)
  • Diagnosed with type 2 diabetes mellitus above or equal to 180 days prior to the day of screening
  • HbA1c (glycated haemoglobin) below or equal to 9.0 percentage at screening
  • Current daily basal insulin treatment of 0.2-1.0 (I)U/kg/day (both inclusive) with or without any of the following anti-diabetic drugs/regimens with stable doses above or equal to 90 days prior to the day of screening:
  • Any metformin formulation
  • Other oral antidiabetic drugs: DPP-4 inhibitors / SGLT2 inhibitors / Oral combination products (for the allowed individual oral antidiabetic drugs)
  • Oral or injectable GLP-1 (glucagon-like peptide 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 (adequate contraceptive measures as required by local regulation or practice).
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): NCT04582448


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

Locations
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Germany
Novo Nordisk Investigational Site Recruiting
Mainz, Germany, 55116
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: NCT04582448    
Other Study ID Numbers: NN1436-4572
U1111-1244-4495 ( Other Identifier: World Health Organization (WHO) )
2019-004660-21 ( Registry Identifier: European Medicines Agency (EudraCT) )
First Posted: October 9, 2020    Key Record Dates
Last Update Posted: November 16, 2020
Last Verified: November 2020
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