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A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Primary Purpose

Diabetes, Healthy

Status

Completed

Phase

Phase 1

Locations

Hungary

Study Type

Interventional

Intervention

insulin degludec

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
Body mass index maximum 40.0 kg/m^2

Exclusion Criteria:

Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function
Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
Significant history of alcoholism or drug/chemical abuse
Not able or willing to refrain from smoking during the inpatient 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

ESRD

Mild

Moderate

Normal

Severe

Arm Description

Outcomes

Primary Outcome Measures

Area under the insulin degludec concentration-time curve

Secondary Outcome Measures

Maximum observed insulin degludec concentration

Renal clearance of insulin degludec after single-dose

Full Information

NCT ID

NCT01006057

First Posted

October 30, 2009

Last Updated

January 19, 2017

Sponsor

Novo Nordisk A/S

1. Study Identification

Unique Protocol Identification Number

NCT01006057

Brief Title

A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Official Title

A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Completed

Study Start Date

November 2009 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novo Nordisk A/S

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

This trial was conducted in Europe. The aim of this clinical trial was to evaluate if the NN1250 (insulin degludec/insulin 454) concentration-time curve is altered to such an extent that the dose should be adjusted in subjects with impaired renal function compared to the dose for subjects with normal renal function.

6. Conditions and Keywords

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

Diabetes, Healthy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

32 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ESRD

Arm Type

Experimental

Arm Title

Mild

Arm Type

Experimental

Arm Title

Moderate

Arm Type

Experimental

Arm Title

Normal

Arm Type

Experimental

Arm Title

Severe

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers

Intervention Type

Drug

Intervention Name(s)

insulin degludec

Intervention Description

Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment

Primary Outcome Measure Information:

Title

Area under the insulin degludec concentration-time curve

Time Frame

from 0 to 120 hours after trial product administration

Secondary Outcome Measure Information:

Title

Maximum observed insulin degludec concentration

Time Frame

from 0 to 120 hours after trial product administration

Title

Renal clearance of insulin degludec after single-dose

Time Frame

from 0 to 24 hours after trial product administration

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis) Body mass index maximum 40.0 kg/m^2 Exclusion Criteria: Subject with any disease or condition which the Investigator feels would interfere with the trial except for conditions associated with renal impairment in the group of subjects with compromised renal function. Diabetes mellitus can be accepted in the group of patients with renal impairment, but not in subjects with normal renal function Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Significant history of alcoholism or drug/chemical abuse Not able or willing to refrain from smoking during the inpatient period

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Registry (GCR, 1452)

Organizational Affiliation

Novo Nordisk A/S

Official's Role

Study Director

Facility Information:

Facility Name

Novo Nordisk Investigational Site

City

Budapest

ZIP/Postal Code

1115

Country

Hungary

12. IPD Sharing Statement

Citations:

PubMed Identifier

24163264

Citation

Kiss I, Arold G, Roepstorff C, Bottcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2.

Results Reference

result

Links:

URL

http://novonordisk-trials.com

Description

Clinical Trials at Novo Nordisk

Learn more about this trial

A Trial Investigating the NN1250 Concentration-time Curve in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

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