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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

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ClinicalTrials.gov Identifier: NCT01006057
Recruitment Status : Completed
First Posted : November 2, 2009
Last Update Posted : January 20, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Diabetes Healthy Drug: insulin degludec Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
Experimental: Mild Drug: insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with mild 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 moderate renal impairment
Experimental: Normal Drug: insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in healthy volunteers
Experimental: Severe Drug: insulin degludec
Single dose of 0.4 U/kg body weight injected s.c. (under the skin) in subjects with severe renal impairment


Outcome Measures

Primary Outcome Measures :
  1. Area under the insulin degludec concentration-time curve [ Time Frame: from 0 to 120 hours after trial product administration ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01006057


Locations
Hungary
Novo Nordisk Investigational Site
Budapest, Hungary, 1115
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
More Information

Additional Information:
Publications:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01006057     History of Changes
Other Study ID Numbers: NN1250-1990
2009-009466-14 ( EudraCT Number )
U1111-1111-0810 ( Other Identifier: WHO )
First Posted: November 2, 2009    Key Record Dates
Last Update Posted: January 20, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Insulin, Globin Zinc
Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs