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Completed

NCT Number: NCT01497600

Pharmacokinetics of Insulin Detemir in Subjects With Type 2 Diabetes

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novo Nordisk Investigational Site

Chula Vista, California, 91911, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

insulin detemir

Drug

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)

insulin NPH

Drug

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)

Primary outcomes

  1. Area under the glucose infusion rate curve

Secondary outcomes

  1. Maximum glucose infusion rate

  2. Time to maximum glucose infusion rate.

  3. Area under the serum insulin curve

  4. Maximum serum insulin concentration

  5. Time to maximum insulin concentration

  6. Terminal rate constant of insulin

  7. Terminal half-life of insulin

  8. Adverse events

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Dec 22, 2011
Registry last updated
Jan 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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