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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01006057

Enrollment

Registered

2009-11-02

Start date

2009-11-30

Completion date

2010-05-31

Last updated

2017-01-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Healthy

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.

Interventions

DRUGinsulin degludec

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

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

Design outcomes

Primary

Measure	Time frame
Area under the insulin degludec concentration-time curve	from 0 to 120 hours after trial product administration

Secondary

Measure	Time frame
Maximum observed insulin degludec concentration	from 0 to 120 hours after trial product administration
Renal clearance of insulin degludec after single-dose	from 0 to 24 hours after trial product administration

Countries

Hungary

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026