Skip to main content
OpenTrials
Completed

NCT Number: NCT01497561

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

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.

Completed

Looking for future studies?

Notify Me

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

Graz, 8036, Germany

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

insulin detemir

Drug

Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)

insulin NPH

Drug

Each subject will be randomly allocated to two dose administrations out of four possible doses. 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

  3. Area under the curve

  4. Maximum concentration

  5. Time to maximum concentration

  6. Insulin clearance

  7. Mean residence time of insulin

  8. Terminal rate constant

  9. Terminal half-life

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.