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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00604344
First received: January 17, 2008
Last updated: January 23, 2012
Last verified: January 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Diabetes
Diabetes Mellitus, Type 1
 Drug: insulin detemir
Drug: insulin NPH
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after 48 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood glucose profiles [ Designated as safety issue: No ]
  • Hypoglycaemic episodes [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Insulin antibodies [ Designated as safety issue: No ]

Enrollment: 401
Study Start Date: April 2003
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604344

Locations
Japan
Tokyo, Japan, 103
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Hiroko Terano Novo Nordisk Pharma Ltd.
Study Director: Hiroaki Arai Novo Nordisk Pharma Ltd.
  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: NCT00604344     History of Changes
Other Study ID Numbers: NN304-1476, JapicCTI-R070008
Study First Received: January 17, 2008
Last Updated: January 23, 2012
Health Authority: Japan: Ministry of Health, Labour and Welfare (MHLW)

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013