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Diabetes Mellitus, Type 2Phase 1NCT03723785

A Research Study of How a New Medicine NNC0148-0287 C (Insulin 287) Works in the Body of People With Kidney Problems

A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be conducted to look at the effect of decreased kidney function when getting one dose of insulin 287 and to guide dosing recommendations in people who have altered kidney function. Insulin 287 works in the body for a long time (long-acting). It is taken once a day by injecting under the skin. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Insulin icodec
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteGermany
Study dates
9 Nov 2018to 6 Sep 2019
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
  • Body mass index between 18.5 and 32.0 kg/sqm (both inclusive).
  • Meeting the pre-defined Glomerular Filtration Rate (GFR) values based on a measured GFR using an exogenous substance as tracer (renal group 1-4) or being in treatment with haemodialysis (renal group 5).

Who cannot join

  • Known or suspected hypersensitivity to trial product or related products.
  • Impaired liver function defined as Alanine Aminotransferase (ALT) greater than or equal to 2.5 times or Bilirubin greater than 1.5 times upper limit of normal at screening.
  • Drugs known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine and trimethoprim within 14 days or 5 half-lives prior to the day of dosing of IMP.
  • Renal group 1 (healthy subjects) exclusively: Unwilling to avoid use of prescription medicinal products or non-prescription drugs, except routine use of vitamins, occasional use of paracetamol, topical medication and contraceptives, within 14 days prior to the day of dosing.
  • Renal Group 2-5 (renal impairment) exclusively: 1) Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. Subjects with heart failure of functional class III-IV according to New York Heart Association (NYHA), subjects with Chronic obstructive pulmonary disease (COPD) grade 4 according to Global Initiative on Obstructive Lung Disease (GOLD), subjects with asthma step 5 according to Global Initiative for Asthma (GINA), subjects diagnosed with diabetes, subjects with uncontrolled treated/untreated hypertension (systolic blood pressure greater than or equal to 180 mmHg and /or diastolic blood pressure greater than or equal to 100 mmHg assessed in supine position) and other co-morbidities in terminal stages or which are decompensated or unstable should not be included in the study. 2) Subject requiring haemodialysis treatment unable or unwilling to undergo haemodialysis scheduled according to the standard clinical regimen throughout the trial period.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité Research Organisation GmbH

    Berlin, 10117

Other trials in Germany

About this study

Official title: Investigation of Pharmacokinetics and Safety Profile of a Single Dose NNC0148-0287 C (Insulin 287) in Subjects With Various Degrees of Renal Impairment

This study will be conducted to look at the effect of decreased kidney function when getting one dose of insulin 287 and to guide dosing recommendations in people who have altered kidney function. Insulin 287 works in the body for a long time (long-acting). It is taken once a day by injecting under the skin. The main target patient group for insulin 287 is people with type 2 diabetes. Participants will get just one injection. The study will last for up to 80 days. Participants will have 11 out-patient visits with the study doctor and one in-house visit of 3 days and 2 nights. Participants will have some assessments like several blood draws, electrocardiograms (ECGs), urine collections and capillary blood sugar tests. Participants cannot take part if they are hypersensitive to the study medicine, if they received any investigational product within 90 days before screening, or if they have certain diseases e.g. HIV or hepatitis or heart problems. Participants have to take photos if they experience any allergic reactions and send them to their study doctor. Participants' kidney function will be examined by a so called "Iohexol test".

Being tested
Insulin icodec
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Insulin icodecDrug

    Also called Insulin 287

    Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1

Study groups in NCT03723785
Study groupRoleWhat they receive
Participants with normal renal functionExperimentalParticipants with normal renal function (glomerular filtration rate [GFR] of greater than or equal to 90 ml/min) will receive single dose of insulin 287 on Day 1.
Receives: Drug: Insulin icodec
Participants with mildly decreased renal functionExperimentalParticipants with mildly decreased renal function (GFR of 60 to less than 90 ml/min) will receive single dose of insulin 287 on Day 1.
Receives: Drug: Insulin icodec
Participants with moderately decreased renal functionExperimentalParticipants with moderately decreased renal function (GFR of 30 to less than 60 ml/min) will receive single dose of insulin 287 on Day 1.
Receives: Drug: Insulin icodec
Participants with severely decreased renal functionExperimentalParticipants with severely decreased renal function (GFR of less than 30 not requiring dialysis) will receive single dose of insulin 287 on Day 1.
Receives: Drug: Insulin icodec
Participants with end-stage renal diseaseExperimentalParticipants with end-stage renal disease requiring haemodialysis will receive single dose of insulin 287 on Day 1.
Receives: Drug: Insulin icodec

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUCI287,0-840h,SD: Area under the serum insulin 287 concentration-time curve after a single dose

    Measured in pmol*h/L

    Measured: From 0 to 840 hours after trial product administration (visit 2 (study day 1))

Secondary outcomes (6)

  1. Cmax,I287,SD: Maximum observed serum insulin 287 concentration after a single dose

    Measured in pmol/L

    Measured: From 0 to tz hours after trial product administration (visit 2 (study day 1)), where tz is the time of the last quantifiable concentration

  2. tmax,I287,SD: Time to maximum observed serum insulin 287 concentration after a single dose

    Measured in hours

    Measured: From 0 to tz hours after trial product administration (visit 2 (study day 1)).

  3. Number of adverse events

    Number of events

    Measured: From trial product administration (visit 2 (study day 1)) until visit 13 (study day 43)

  4. Change in anti-insulin 287 antibody level

    Measured in % B/T (percentage of bound tracer measured after precipitation to total tracer)

    Measured: From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)

  5. Change in anti-insulin 287 antibody titres

    Number of dilutions

    Measured: From visit 2 (study day 1, pre-dose) to visit 13 (study day 43)

  6. Positive cross-reactive anti-human insulin antibodies

    Number of patients with/without positive cross-reactive anti-human insulin antibodies

    Measured: At visit 13 (study day 43)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2018
  2. Study start9 Nov 2018
  3. Primary completion6 Sep 2019
  4. Study completion6 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03723785
Sponsor's protocol ID
NN1436-4226
Other IDs
2017-004529-34, U1111-1204-8972, 2017
Status last verified
Jul 2024
First submitted
26 Oct 2018
Last updated
12 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Publications

  • Haahr H, Cieslarova B, Hingst JR, Jiang S, Kristensen NR, Kupcova V, Norgreen L, Wagner FH, Ignatenko S. The Effect of Various Degrees of Renal or Hepatic Impairment on the Pharmacokinetic Properties of Once-Weekly Insulin Icodec. Clin Pharmacokinet. 2024 Jun;63(6):819-830. doi: 10.1007/s40262-024-01375-2. Epub 2024 May 9.

    PubMed 38722461

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Insulin icodec in people with Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUCI287,0-840h,SD: Area under the serum insulin 287 concentration-time curve after a single dose (time frame: From 0 to 840 hours after trial product administration (visit 2 (study day 1))). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03723785, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2024.

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