Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: April 5, 2006
Last updated: January 26, 2017
Last verified: January 2017
The trial is conducted in Europe and Africa. The aim of the trial is to compare the use of insulin detemir twice daily combined with mealtime insulin aspart against that of insulin glargine once daily combined with mealtime insulin aspart. The trial involves patients with Type 1 Diabetes.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Comparison of Efficacy and Safety of Insulin Detemir and Insulin Glargine in Patients With Type 1 Diabetes.

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:
  • Adverse events
  • Body weight
  • Blood glucose
  • Hypoglycaemia

Enrollment: 325
Study Start Date: April 2002
Study Completion Date: March 2003
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)

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

Inclusion Criteria:

  • Type 1 diabetes for at least 12 months
  • Current daily insulin dose of more than 1.4 IU/kg
  • BMI lesser than or equal to 35 kg/m2
  • HbA1c greater than 7.5% and less than or equal to 12.0%
  • In Austria, age more than 19 years

Exclusion Criteria:

  • Proliferate retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Any condition or disease such as uncontrolled hypertension or AIDS/HIV that rule out trial participation according to the judgement of the investigator
  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 identifier: NCT00312104

  Show 46 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00312104     History of Changes
Other Study ID Numbers: NN304-1372
Study First Received: April 5, 2006
Last Updated: January 26, 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
Insulin Aspart
Insulin Detemir
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017