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Pharmacodynamics and Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01497561
First received: December 20, 2011
Last updated: NA
Last verified: December 2011
History: No changes posted
  Purpose

This trial is conducted in Europe. The aim of this trial is to investigate the pharmacodynamics and pharmacokinetics of single doses of insulin detemir and insulin NPH in subjects with type 2 diabetes.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 2
 Drug: insulin detemir
Drug: insulin NPH
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Four-period, Cross-over, Dose Response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects With Type 2 Diabetes

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • Area under the glucose infusion rate curve [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum glucose infusion rate [ Designated as safety issue: No ]
  • Time to maximum glucose [ Designated as safety issue: No ]
  • Area under the curve [ Designated as safety issue: No ]
  • Maximum concentration [ Designated as safety issue: No ]
  • Time to maximum concentration [ Designated as safety issue: No ]
  • Insulin clearance [ Designated as safety issue: No ]
  • Mean residence time of insulin [ Designated as safety issue: No ]
  • Terminal rate constant [ Designated as safety issue: No ]
  • Terminal half-life [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: March 2003
Study Completion Date: June 2003
Primary Completion Date: June 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin detemir Drug: insulin detemir
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
Active Comparator: insulin NPH Drug: insulin NPH
Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Subjects treated with insulin for minimum 3 months
  • Duration of diabetes for at least 12 months
  • Body Mass Index (BMI) below 30 kg/m^2
  • HbA1c maximum 10% based on analysis from central laboratory

Exclusion Criteria:

  • Current treatment with insulin above 1.2 U/kg/day
  • Current treatment with insulin glargine
  • Current treatment with drugs known to interfere with glucose metabolism
  • Current treatment with oral antidiabetic drugs
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01497561

Locations
Austria
Graz, Austria, 8036
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Lisbeth V. Jacobsen Novo Nordisk
  More Information

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

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01497561     History of Changes
Other Study ID Numbers: NN304-1538
Study First Received: December 20, 2011
Last Updated: December 20, 2011
Health Authority: Austria: The Austrian Agency for Health and Food Safety (AGES)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
 Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013