Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00184665

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 Mellitus, Type 1	Drug: insulin detemir Drug: insulin NPH Drug: insulin aspart	Phase III

MedlinePlus related topics: Diabetes Diabetes Type 1 Hypoglycemia

Drug Information available for: Insulin Insulin aspart Insulin Detemir Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	2 Year Efficiency and Safety Comparison of Insulin Detemir and NPH Insulin in Type 1 Diabetes.

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 ]

Estimated Enrollment:	500
Study Start Date:	June 2004

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

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

Responsible Party:	Novo Nordisk A/S ( Public Access to Clinical Trials )
Study ID Numbers:	NN304-1595
Study First Received:	September 13, 2005
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00184665
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: India's Drug Controller General, a division of the Ministry of

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Insulin, Asp(B28)-
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Immune System Diseases
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009