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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

NCT01006057 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2017-01-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

insulin degludec

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

DRUG

insulin degludec

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

DRUG

insulin degludec

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

DRUG

insulin degludec

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

DRUG

insulin degludec

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

Sponsors & Collaborators

Principal Investigators

  • Global Clinical Registry (GCR, 1452) · Novo Nordisk A/S

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • Hungary

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01006057 on ClinicalTrials.gov