A Study to Test How a New Long-acting Insulin (Insulin Icodec) Works in the Body of People From China With Type 2 Diabetes

Sponsor
Novo Nordisk A/S (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04857398
Collaborator
(none)
120
Enrollment
1
Location
1
Arm
11.4
Anticipated Duration (Months)
10.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study is looking at the way insulin icodec stays and moves over time in the blood after injections in Chinese people with type 2 diabetes.

Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin of the thigh. There will also be a run-in period that will last between 1 week and 8 weeks with daily doses of insulin degludec before start on insulin icodec.

The study will last for about 15 to 22 weeks. Participants will have about 17 visits with the study doctor including phone contact during your run-in period.

Participants will have blood samples taken at the clinic visits. Several samples of participants blood will be taken for up to 48 hours after getting the first and the last dose of insulin icodec.

Participants must be a Chinese person diagnosed with type 2 diabetes for at least 6 months and be on basal insulin treatment for at least 2 months before participating in the study.

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

Condition or DiseaseIntervention/TreatmentPhase
  • Drug: insulin icodec
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Trial Investigating the Pharmacokinetic Properties of Insulin Icodec in Chinese Subjects With Type 2 Diabetes
Actual Study Start Date :
Apr 28, 2021
Anticipated Primary Completion Date :
Apr 11, 2022
Anticipated Study Completion Date :
Apr 11, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Insulin icodec

The participants will receive an individualised weekly dose of subcutaneously (s.c.) insulin icodec for 6 weeks

Drug: insulin icodec
Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin. The study will last for 15 to 22 weeks.

Outcome Measures

Primary Outcome Measures

  1. 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)]

    pmol*h/L

Secondary Outcome Measures

  1. Area under the serum insulin icodec concentration-time curve during one dosing interval at steady state divided by dose [From 0 to 168 hours after trial product administration (Day 36)]

    (pmol*h/L)/(U/kg)

  2. Maximum observed serum insulin icodec concentration after the last dose [From 0 to 168 hours after trial product administration (Day 36)]

    pmol/L

  3. Maximum observed serum insulin icodec concentration after the last dose divided by dose [From 0 to 168 hours after trial product administration (Day 36)]

    (pmol/L)/(U/kg)

  4. Time to maximum observed serum insulin icodec concentration after the last dose [From 0 to 168 hours after trial product administration (Day 36)]

    hours

  5. Terminal half-life for insulin icodec at steady state [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 36)]

    hours

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Chinese male or female

  • Aged 18-64 years (both inclusive) at the time of signing informed consent

  • Body mass index between 18 and 38 kg/m^2 (both inclusive)

  • HbA1c (glycated haemoglobin) below or equal to 9% at screening

  • Current daily basal insulin treatment greater than or equal to 0.2 (I)U/kg/day greater than or equal to 60 days prior to the day of screening with or without any of the following anti-diabetic drugs/regimens with stable doses greater than or equal to 60 days prior to the day of screening:

  • Any metformin formulation

  • Other oral antidiabetic drugs: DPP-4 (Dipeptidyl-peptidase-4) Inhibitors , SGLT2 (Sodium-glucose co-transporter-2) 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).

  • 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 run-in. 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Novo Nordisk Investigational SiteBeijingBeijingChina100853

Sponsors and Collaborators

  • Novo Nordisk A/S

Investigators

  • Study Director: Clinical Transparency (Dept.1452), Novo Nordisk A/S

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT04857398
Other Study ID Numbers:
  • NN1436-4571
  • U1111-1244-4473
First Posted:
Apr 23, 2021
Last Update Posted:
Nov 17, 2021
Last Verified:
Nov 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 17, 2021