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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ESRD

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

Mild

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

Moderate

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

Normal

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

Severe

Group Type EXPERIMENTAL

insulin degludec

Intervention Type DRUG

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

Interventions

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insulin degludec

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

insulin degludec

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

Intervention Type DRUG

insulin degludec

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

Intervention Type DRUG

insulin degludec

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

Intervention Type DRUG

insulin degludec

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No