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NCT Number: NCT01006057

A Trial Investigating the NN1250 Concentration-time Curve 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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Healthy Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Budapest, 1115, Hungary

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin degludec

Drug

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

Primary outcomes

  1. Area under the insulin degludec concentration-time curve

    Time frame: from 0 to 120 hours after trial product administration

Secondary outcomes

  1. Maximum observed insulin degludec concentration

    Time frame: from 0 to 120 hours after trial product administration

  2. Renal clearance of insulin degludec after single-dose

    Time frame: from 0 to 24 hours after trial product administration

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A Trial Investigating the Pharmacokinetic and Safety of NN1250 in Subjects With Various Degrees of Renal Impairment and in Subjects With Normal Renal Function

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 2, 2009
Registry last updated
Jan 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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