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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00312104
First received: April 5, 2006
Last updated: June 11, 2014
Last verified: June 2014
  Purpose

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
Diabetes Mellitus, Type 1
Drug: insulin detemir
Drug: insulin glargine
Drug: insulin aspart
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: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events [ Designated as safety issue: Yes ]
  • Body weight [ Designated as safety issue: No ]
  • Blood glucose [ Designated as safety issue: No ]
  • Hypoglycaemia [ Designated as safety issue: Yes ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00312104

Locations
Austria
Graz, Austria, 8036
Germany
Völklingen, Germany, 66333
South Africa
Durban, KwaZulu-Natal, South Africa, 4091
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00312104     History of Changes
Other Study ID Numbers: NN304-1372
Study First Received: April 5, 2006
Last Updated: June 11, 2014
Health Authority: South Africa: Medicines Control Council
Austria: Federal Ministry for Health and Women
Germany: Federal Institute for Drugs and Medical Devices

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
Glargine
Insulin
Insulin, Long-Acting
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014