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

Phase 1

Completed

• Conditions: Diabetes; Healthy
• Interventions: Drug: insulin degludec

• Registration Number: NCT01006057
• Lead Sponsor: Novo Nordisk A/S

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-10-30
• Study First Submitted QC: 2009-10-30
• Study Start: 2009-11
• Study First Posted: 2009-11-01
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-19
• Last Update Posted: 2017-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ESRD	insulin degludec	-
Mild	insulin degludec	-
Moderate	insulin degludec	-
Normal	insulin degludec	-
Severe	insulin degludec	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Novo Nordisk Investigational Site; 🇭🇺 Budapest, Hungary