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

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Healthy; Diabetes

Treatments: Drug: insulin degludec

Study type: Interventional

Funder types: Industry

Identifiers

NCT01006057

2009-009466-14 (EudraCT Number)

U1111-1111-0810 (Other Identifier)

NN1250-1990

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 5 patient groups

ESRD

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Mild

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Moderate

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Normal

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Severe

Experimental group

Treatment:

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec

Drug: insulin degludec