Skip to main content
OpenTrials
Completed

NCT Number: NCT00604344

Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes

This trial is conducted in Japan. The aim of this trial is to investigate the efficacy of insulin detemir on blood glucose control in subjects with insulin requiring diabetes.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site

Tokyo, 1000005, Japan

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Duration of diabetes mellitus for at least 2 years
  • Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart
  • HbA1C below 11.0%

Exclusion criteria

  • Impaired renal function
  • Impaired hepatic function
  • Serious heart diseases
  • Known hypoglycaemia unawareness or recurrent major hypoglycaemia
  • Proliferative retinopathy or maculopathy requiring acute treatment
  • Uncontrolled treated/untreated hypertension
  • Current treatment with total insulin dose of more than 100 IU/day
  • Current treatment or expected at the screening to start treatment with systemic corticosteroids

Treatment and study plan

insulin detemir

Drug

insulin NPH

Drug

Primary outcomes

  1. HbA1c

    Time frame: after 48 weeks of treatment

Secondary outcomes

  1. Blood glucose profiles

  2. Hypoglycaemic episodes

  3. Adverse events

  4. Body weight

  5. Insulin antibodies

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

A 48-week, Randomised, Multi-centre, Openlabelled, Parallel-group Trial to Compare the Efficacy and the Safety of NN304 (Insulin Detemir) and NPH Human Insulin in Subjects With Insulin Requiring Diabetes Mellitus on a Basal-bolus Regimen

Important dates

Study start
2003
Primary completion
2005
Study completion
2005
First posted
Jan 30, 2008
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.