A Study of Basal Rate Changes in Patients With Type-1 Diabetes Mellitus - Full Text View

Sponsored by:	Hoffmann-La Roche
Information provided by:	Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00772356

Purpose

This crossover, glucose-clamp study will investigate the impact of different basal insulin infusion rates on glucose control employing insulin pumps with different insulin delivery regimen. Patients will be randomized in one of 2 groups, to receive on the first study day insulin via pumps with pulsatile or quasi-continuous delivery modes. On the second study day they will be switched to treatment with the alternative delivery regimen. The anticipated duration of the trial is 2 study days and the target sample size is 14 individuals.

Condition	Intervention
Diabetes Mellitus, Type 1	Device: Accu-Chek Spirit Pump

MedlinePlus related topics: Diabetes Diabetes Type 1

Drug Information available for: Insulin Dextrose Proparacaine Proparacaine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Open Label, Crossover Assignment
Official Title:	A Monocenter, Open-Label Glucose Clamp Study Examining the Metabolic Effect of Insulin Infusion Intervals for Basal Infusion in Patients With Type-1 Diabetes

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Comparison of glucose infusion rate necessary to keep blood glucose constant [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Serum insulin and free fatty acid levels [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Estimated Enrollment:	14
Study Start Date:	January 2008
Study Completion Date:	May 2008

Intervention Details:

Patients undergo an in-house glucose clamp procedure to measure the effects of basal rates changes on glucose levels.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

male patients, 18-65 years of age;
type-1 diabetes mellitus
currently on continuous subcutaneous insulin infusion therapy

Exclusion Criteria:

proliferative retinopathy or maculopathy requiring acute treatment within last 6 months
use of systemic corticoids in last 3 months
treatment with medication known to interfere with glucose metabolism

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772356

Locations

Germany

Neuss, Germany

Sponsors and Collaborators

Hoffmann-La Roche

More Information

Responsible Party:	Hoffmann-La Roche ( Clinical Trials )
Study ID Numbers:	RD000559
Study First Received:	October 13, 2008
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00772356
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Hoffmann-La Roche:

Diabetes

Study placed in the following topic categories:

Autoimmune Diseases
Metabolic Diseases
Diabetes Mellitus, Type 1
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Proxymetacaine
Metabolic disorder
Glucose Metabolism Disorders
Insulin

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009