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Efficacy and Safety of Insulin Detemir in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00595374
First received: January 7, 2008
Last updated: February 22, 2017
Last verified: February 2017
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

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

Secondary Outcome Measures:
  • Plasma glucose profiles
  • Change in body weight
  • Quality of Life
  • Incidence of adverse events
  • Incidence of hypoglycaemic episodes

Enrollment: 114
Actual Study Start Date: December 2, 2003
Study Completion Date: October 7, 2004
Primary Completion Date: October 7, 2004 (Final data collection date for primary outcome measure)
  Eligibility

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00595374

Locations
Netherlands
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
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00595374     History of Changes
Other Study ID Numbers: NN304-1582
Study First Received: January 7, 2008
Last Updated: February 22, 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 degludec, insulin aspart drug combination
Insulin
Insulin Detemir
Isophane Insulin, Human
Insulin, Isophane
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 26, 2017