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Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01497600
First received: December 20, 2011
Last updated: January 26, 2017
Last verified: January 2017
  Purpose
This trial is conducted in the United States of America (USA). The aim of this trial is to evaluate the the dose-response of insulin detemir and insulin NPH in subjects with type 2 diabetes of various race and ethnicity.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomised, Double-blind, Six-period, Cross-over, Dose-response Trial Investigating the Pharmacodynamics and Pharmacokinetics of Single Doses of Insulin Detemir and NPH Insulin in Subjects of Blacks or African American, Whites of Hispanic or Latino Origin and Whites Not of Hispanic or Latino Origin With Type 2 Diabetes

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Area under the glucose infusion rate curve

Secondary Outcome Measures:
  • Maximum glucose infusion rate
  • Time to maximum glucose infusion rate.
  • Area under the serum insulin curve
  • Maximum serum insulin concentration
  • Time to maximum insulin concentration
  • Terminal rate constant of insulin
  • Terminal half-life of insulin
  • Adverse events

Enrollment: 50
Study Start Date: February 2004
Study Completion Date: August 2004
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: insulin detemir Drug: insulin detemir
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Drug: insulin NPH
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Active Comparator: insulin NPH Drug: insulin detemir
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
Drug: insulin NPH
Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes
  • Insulin treatment with any insulin preparation/regimen for at least three months with or without combination with below or equal to 2 oral antidiabetic agents (OADs)
  • Duration of diabetes at least 12 months
  • Body Mass Index (BMI) below 33 kg/m^2
  • HbA1c maximum 10 % based on analysis from the central laboratory

Exclusion Criteria:

  • Current treatment with insulin above 1.2 U/kg/day
  • Current treatment with drugs known to interfere with glucose metabolism other than OADs such as systemic corticosteroids, non-selective beta-blockers, and monoamino oxidase (MAO) inhibitors
  • Blood donation of more than 500 mL within the last three months
  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: NCT01497600

Locations
United States, California
Novo Nordisk Investigational Site
Chula Vista, California, United States, 91911
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: NCT01497600     History of Changes
Other Study ID Numbers: NN304-1439
Study First Received: December 20, 2011
Last Updated: January 26, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 21, 2017