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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

Insulin icodec

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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.

Sites / Locations

Novo Nordisk Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Participants with normal renal function

Participants with mildly decreased renal function

Participants with moderately decreased renal function

Participants with severely decreased renal function

Participants with end-stage renal disease

Arm Description

Participants 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.

Participants with mildly decreased renal function (GFR of 60 to less than 90 ml/min) will receive single dose of insulin 287 on Day 1.

Participants with moderately decreased renal function (GFR of 30 to less than 60 ml/min) will receive single dose of insulin 287 on Day 1.

Participants with severely decreased renal function (GFR of less than 30 not requiring dialysis) will receive single dose of insulin 287 on Day 1.

Participants with end-stage renal disease requiring haemodialysis will receive single dose of insulin 287 on Day 1.

Outcomes

Primary Outcome Measures

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

Measured in pmol*h/L

Secondary Outcome Measures

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

Measured in pmol/L

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

Measured in hours

Number of adverse events

Number of events

Change in anti-insulin 287 antibody level

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

Change in anti-insulin 287 antibody titres

Number of dilutions

Positive cross-reactive anti-human insulin antibodies

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

Full Information

NCT ID

NCT03723785

First Posted

October 26, 2018

Last Updated

March 5, 2021

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT03723785

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Completed

Study Start Date

November 9, 2018 (Actual)

Primary Completion Date

September 6, 2019 (Actual)

Study Completion Date

September 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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".

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

58 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Participants with normal renal function

Arm Type

Experimental

Arm Description

Participants 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.

Arm Title

Participants with mildly decreased renal function

Arm Type

Experimental

Arm Description

Participants with mildly decreased renal function (GFR of 60 to less than 90 ml/min) will receive single dose of insulin 287 on Day 1.

Arm Title

Participants with moderately decreased renal function

Arm Type

Experimental

Arm Description

Participants with moderately decreased renal function (GFR of 30 to less than 60 ml/min) will receive single dose of insulin 287 on Day 1.

Arm Title

Participants with severely decreased renal function

Arm Type

Experimental

Arm Description

Participants with severely decreased renal function (GFR of less than 30 not requiring dialysis) will receive single dose of insulin 287 on Day 1.

Arm Title

Participants with end-stage renal disease

Arm Type

Experimental

Arm Description

Participants with end-stage renal disease requiring haemodialysis will receive single dose of insulin 287 on Day 1.

Intervention Type

Drug

Intervention Name(s)

Insulin icodec

Other Intervention Name(s)

Insulin 287

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Measured in pmol*h/L

Time Frame

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

Secondary Outcome Measure Information:

Title

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

Description

Measured in pmol/L

Time Frame

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

Title

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

Description

Measured in hours

Time Frame

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

Title

Number of adverse events

Description

Number of events

Time Frame

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

Title

Change in anti-insulin 287 antibody level

Description

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

Time Frame

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

Title

Change in anti-insulin 287 antibody titres

Description

Number of dilutions

Time Frame

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

Title

Positive cross-reactive anti-human insulin antibodies

Description

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

Time Frame

At visit 13 (study day 43)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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). Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Reporting Anchor and Disclosure (1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Berlin

ZIP/Postal Code

10117

Country

Germany

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

IPD Sharing URL

http://novonordisk-trials.com

Learn more about this trial

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

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