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Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00184665
First received: September 13, 2005
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

This trial is conducted in Africa, Asia, Europe, Oceania, and South America. The aim of this research study is to compare the efficacy (reduction in HbA1c and in blood glucose levels) of insulin detemir compared to NPH insulin administered as basal insulin for the treatment of type 1 diabetes and to verify the safety of use (number and severity of episodes of hypoglycemia, body weight, and insulin antibodies and side effects).


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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:
  • HbA1c [ Time Frame: after a two-year trial period ] [ Designated as safety issue: No ]

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

Enrollment: 501
Study Start Date: June 2004
Study Completion Date: September 2006
Primary Completion Date: September 2006 (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
  • Currently on basal-bolus regimen
  • BMI = 35.0 kg/m2
  • HbA1c =11.0%

Exclusion Criteria:

  • Proliferative retinopathy or maculopathy
  • Recurrent major hypoglycaemia
  • Cardial problems
  • Uncontrolled hypertension
  • Impaired hepatic or renal function
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00184665

Locations
Argentina
Buenos Aires, Argentina
Australia
Brisbane, Australia
Bulgaria
Sofia, Bulgaria
Croatia
Zagreb, Croatia
India
Chennai, India
Macedonia, The Former Yugoslav Republic of
Skopje, Macedonia, The Former Yugoslav Republic of
Malaysia
Kota Bharu, Kelantan, Malaysia
Romania
Bucharest, Romania
South Africa
Johannesburg, South Africa
Turkey
Istanbul, Turkey
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Jens Larsen Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00184665     History of Changes
Other Study ID Numbers: NN304-1595
Study First Received: September 13, 2005
Last Updated: June 19, 2012
Health Authority: Croatia: Ministry of Health and Social Care
Turkey: Ministry of Health Drug and Pharmaceutical Department
Romania: National Medicines Agency
Bulgaria: Bulgarian Drug Agency
South Africa: Medicines Control Council
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia
Australia: Department of Health and Ageing Therapeutic Goods Administration
Malaysia: Ministry of Health
India: Ministry of Health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, NPH
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013