The Effect of Exercise on Blood Glucose Levels in Patients With Type 1 Diabetes: A Comparison of 3 Long-Acting Insulins - Full Text View

Sponsored by:	Novo Nordisk
Information provided by:	Novo Nordisk
ClinicalTrials.gov Identifier:	NCT00313742

Purpose

This trial is conducted in Europe. The aim of this research is to assess the impact of three basal (long-acting) insulin treatments on blood glucose levels in people with type 1 diabetes when performing physical exercise.

Condition	Intervention	Phase
Diabetes Mellitus, Type 1	Drug: insulin detemir Drug: insulin glargine Drug: insulin NPH	Phase IV

MedlinePlus related topics: Diabetes Diabetes Type 1 Exercise and Physical Fitness

Drug Information available for: Insulin Insulin glargine Insulin Detemir Dextrose Insulin, isophane

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	An Assessment of the Impact of Performing Physical Exercise on the Maximum Plasma Glucose Decline in Subjects With Type 1 Diabetes Managed on a Basal Bolus Insulin Regimen: A Comparison of 3 Basal Insulin Treatments - Insulin Detemir, Insulin Glargine and NPH Insulin

Further study details as provided by Novo Nordisk:

Primary Outcome Measures:

The difference between plasma glucose concentrations immediately pre-exercise and the minimum plasma glucose concentrations (nadir) in the period 0-150 min following exercise [ Time Frame: following 4 weeks of treatment ]

Secondary Outcome Measures:

Plasma glucose pre-exercise & post-exercise
Hypoglycaemia episodes (major and minor episodes) during exercise, afterwards & from end of study until 07:30 the following morning
Plasma glucose profile post-exercise
Incidence of adverse events during the trial

Estimated Enrollment:	50
Study Start Date:	March 2006

Eligibility

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

Criteria

Inclusion Criteria:

Type 1 Diabetes
Current basal-bolus insulin therapy
HbA1c < 10%
BMI < 32 kg/m2

Exclusion Criteria:

Proliferative Retinopathy / Maculopathy
Recurrent major hypoglycaemias
Impaired hepatic or renal function
Cardiac Problems
Uncontrolled hypertension

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313742

Locations

Germany

Neuss, Germany
United Kingdom

Newcastle upon Tyne, United Kingdom

Sponsors and Collaborators

Novo Nordisk

Investigators

Study Director:

Bodil Elbroend, MD

Novo Nordisk Pharma. Ltd

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:	NN304-1724
Study First Received:	April 11, 2006
Last Updated:	December 1, 2008
ClinicalTrials.gov Identifier:	NCT00313742
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices; United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study placed in the following topic categories:

Insulin, Long-Acting
Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Glargine
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 16, 2009