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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01006057
First received: October 30, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Europe. The aim of this clinical trial is to evaluate if the NN1250 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.


Condition Intervention Phase
Diabetes
Healthy
 Drug: NN1250
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the NN1250 concentration-time curve [ Time Frame: from 0 to 120 hours after trial product administration ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum observed NN1250 concentration [ Time Frame: from 0 to 120 hours after trial product administration ] [ Designated as safety issue: No ]
  • Renal clearance of NN1250 after single-dose [ Time Frame: from 0 to 24 hours after trial product administration ] [ Designated as safety issue: No ]

Enrollment: 32
Study Start Date: November 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: NN1250
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
Experimental: B Drug: NN1250
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild renal impairment
Experimental: C Drug: NN1250
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with moderate renal impairment
Experimental: D Drug: NN1250
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment
Experimental: E Drug: NN1250
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with end stage renal disease

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject with normal renal function or renal impairment (mild, moderate, severe or end stage renal disease (ESRD) requiring haemodialysis)
  • Body mass index equal or below 40.0 kg/m2

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 trial start
  • Significant history of alcoholism or drug/chemical abuse
  • Not able or willing to refrain from smoking during the inpatient period
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01006057

Locations
Hungary
Budapest, Hungary, 1115
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Marianne Thrane, MSc.PhD Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Novo Nordisk
ClinicalTrials.gov Identifier: NCT01006057     History of Changes
Other Study ID Numbers: NN1250-1990, 2009-009466-14, U1111-1111-0810
Study First Received: October 30, 2009
Last Updated: June 29, 2012
Health Authority: Hungary: National Institute of Pharmacy

ClinicalTrials.gov processed this record on May 19, 2013