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Efficacy and Safety of Insulin Detemir in Type 1 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: NCT00595374
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : February 24, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:

This trial is conducted in Europe.

The aim of this trial is to compare the efficacy and safety of insulin detemir and insulin NPH in adults with type 1 diabetes on blood glucose control.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Comparison of Insulin Detemir Plus Insulin Aspart to Insulin NPH Plus Insulin Aspart in Adults With Type 1 Diabetes Mellitus
Actual Study Start Date : December 2, 2003
Actual Primary Completion Date : October 7, 2004
Actual Study Completion Date : October 7, 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. HbA1c [ Time Frame: after 26 weeks of treatment ]

Secondary Outcome Measures :
  1. Plasma glucose profiles
  2. Change in body weight
  3. Quality of Life
  4. Incidence of adverse events
  5. Incidence of hypoglycaemic episodes

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Duration of type 1 diabetes for at least 12 months
  • BMI below 35 kg/m2
  • HbA1c between 7.0-12.0%
  • Current treatment with preprandial short acting insulin and insulin NPH once or twice daily for at least 6 months
  • Fertile females must use acceptable method of contraception if there is any risk of pregnancy in the opinion of the Investigator

Exclusion Criteria:

  • Known or suspected allergy to trial product or related products
  • Previous participation in this trial
  • Receipt of any investigational products within the last 2 months prior to this trial
  • Drug or alcohol dependence
  • Pregnancy, breast-feeding or intention of becoming pregnant

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): NCT00595374

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Novo Nordisk Investigational Site
Amersfoort, Netherlands, 3818 ES
Novo Nordisk Investigational Site
Apeldoorn, Netherlands, 7334 DZ
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2566 MJ
Novo Nordisk Investigational Site
Den Haag, Netherlands, 2597 AX
Novo Nordisk Investigational Site
Den Helder, Netherlands, 1782 GZ
Novo Nordisk Investigational Site
Deventer, Netherlands, 7415 CM
Novo Nordisk Investigational Site
Enschede, Netherlands, 7511 JX
Novo Nordisk Investigational Site
Gouda, Netherlands, 2805 AH
Novo Nordisk Investigational Site
Hoogeveen, Netherlands, 7909 AA
Novo Nordisk Investigational Site
Leidschendam, Netherlands, 2262 BA
Novo Nordisk Investigational Site
Meppel, Netherlands, 7943 KA
Novo Nordisk Investigational Site
Rotterdam, Netherlands, 3083 AN
Novo Nordisk Investigational Site
Stadskanaal, Netherlands, 9501 EH
Novo Nordisk Investigational Site
Utrecht, Netherlands, 3563 AZ
Novo Nordisk Investigational Site
Waalwijk, Netherlands, 5141 BM
Novo Nordisk Investigational Site
Weert, Netherlands, 6001 BE
Novo Nordisk Investigational Site
Zevenaar, Netherlands, 6903 ZN
Novo Nordisk Investigational Site
Zwolle, Netherlands, 8025 AB
Sponsors and Collaborators
Novo Nordisk A/S
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
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Responsible Party: Novo Nordisk A/S Identifier: NCT00595374     History of Changes
Other Study ID Numbers: NN304-1582
First Posted: January 16, 2008    Key Record Dates
Last Update Posted: February 24, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin Aspart
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Isophane insulin, beef
Hypoglycemic Agents
Physiological Effects of Drugs