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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Diabetes
• Intervention / Treatment: Drug: insulin degludec; Drug: insulin degludec; Drug: insulin degludec; Drug: insulin degludec; Drug: insulin degludec

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Phase 1

Contacts and Locations

Study Locations

• Hungary
  • Budapest, Hungary, 1115
    • Novo Nordisk Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Normal	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
Experimental: ESRD	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
Experimental: Mild	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
Experimental: Moderate	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
Experimental: Severe	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S

Publications and helpful links

General Publications

• Kiss I, Arold G, Roepstorff C, Bottcher SG, Klim S, Haahr H. Insulin degludec: pharmacokinetics in patients with renal impairment. Clin Pharmacokinet. 2014 Feb;53(2):175-83. doi: 10.1007/s40262-013-0113-2.

Helpful Links

• Clinical Trials at Novo Nordisk

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: October 30, 2009
• First Submitted That Met QC Criteria: October 30, 2009
• First Posted (Estimate): November 1, 2009

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin, Long-Acting
• Other Study ID Numbers: NN1250-1990; 2009-009466-14 (EudraCT Number); U1111-1111-0810 (Other Identifier: WHO)