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 A/S
ClinicalTrials.gov Identifier:
NCT01006057
First received: October 30, 2009
Last updated: October 25, 2013
Last verified: October 2013
  Purpose

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 Intervention Phase
Diabetes
Healthy
Drug: insulin degludec
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

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

  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 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01006057

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

Additional Information:
No publications provided by Novo Nordisk A/S

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novo Nordisk A/S
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: October 25, 2013
Health Authority: Hungary: National Institute of Pharmacy

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

ClinicalTrials.gov processed this record on October 23, 2014