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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00604344
Recruitment Status : Completed
First Posted : January 30, 2008
Last Update Posted : January 27, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
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 or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: insulin detemir Drug: insulin NPH Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 401 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2003
Actual Primary Completion Date : March 2005
Actual Study Completion Date : March 2005

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 48 weeks of treatment ]

Secondary Outcome Measures :
  1. Blood glucose profiles
  2. Hypoglycaemic episodes
  3. Adverse events
  4. Body weight
  5. Insulin antibodies

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00604344

Novo Nordisk Investigational Site
Tokyo, Japan, 1000005
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Kobayashi M, Iwamoto Y, Kaku K, Kawamori R, Tajima N. 48-week Randomized Multicenter Open-label Parallel Group Phase 3 Trial to Compare Insulin Detemir and NPH Insulin Efficacy and Safety in Subjects with Insulin Requriring Diabetes Mellitus in a Basal-bolus Regimen. J. Japan Diab. Soc 2007; 50 (9): 649-663
Kobayashi M, Iwamoto Y, Kawamori R, Tajima N, Nishida T, Kaku K. Insulin detemir achieves lower, less variable fasting glucose and a reduced risk of nocturnal hypoglycaemia and weight gain compared to NPH insulin in basal bolus therapy of Japanese patients with type 1 diabetes. Diabetologia 2006; 49 (Suppl 1): A608-A609 [Abstract 995]
Ishii H, Iwamoto Y, Kaku K, Kawamori R, Tajima N, Kobayashi M. Quality of Life (QoL) Assessment of Insulin Detemir and NPH Human Insulin in Japanese Subjects with Diabetes on Basal-Bolus Regimen. Diabetes 2007; 56 (Suppl. 1): A170 (2805-PO)

Responsible Party: Novo Nordisk A/S Identifier: NCT00604344     History of Changes
Other Study ID Numbers: NN304-1476
JapicCTI-R070008 ( Registry Identifier: JAPIC )
First Posted: January 30, 2008    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Isophane insulin, beef
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs