LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

This study has been completed.

First Received: April 27, 2006 Last Updated: September 11, 2007 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00322075

Purpose

Comparison of incidence of hypoglycaemic events and glycaemic fluctuations in diabetic patients with basal substitution with NPH insuline versus insuline glargine. Evaluation of HbA1c, FBG (Fasting Blood Glucose), BMI (Body Mass Index), dose of insulin, ratio of basal and prandial insulin, satisfaction with treatment, incidence of adverse events.

Condition	Intervention	Phase
Diabetes Mellitus	Drug: insulin glargine	Phase IV

MedlinePlus related topics: Diabetes

Drug Information available for: Insulin Insulin glargine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

3 days continual glycaemic profile fluctuation
occurrence of adverse events
HbA1c
FBG
BMI
total daily dose of insulin and ratio of doses of basal/prandial insulines
patients´satisfaction

Estimated Enrollment:	35
Study Start Date:	April 2006
Estimated Study Completion Date:	November 2006

Eligibility

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

Criteria

Inclusion Criteria:

Patients with Diabetes Mellitus Type 1 and Diabetes Mellitus Type 2 with HbA1c 6% and more with more than 2 confirmed hypoglycaemic events (glycaemia less than 3,3 mmol/l) during last year

Exclusion Criteria:

Diabetic ketoacidosis
Any other severe disease
Pregnancy or fertile female without contraception
Alcohol/drug abuse, selected prohibited concomitant medication
Nightshift work

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00322075

Locations

Czech Republic
Sanofi-Aventis
Prague, Czech Republic

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

Zuzana Priborska

Sanofi-Aventis

More Information

No publications provided

Study ID Numbers:	LANTU_L_00722, EudraCT # : 2006-000122-31
Study First Received:	April 27, 2006
Last Updated:	September 11, 2007
ClinicalTrials.gov Identifier:	NCT00322075 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Study placed in the following topic categories:

Hypoglycemic Agents
Metabolic Diseases
Glargine
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Glucose Metabolism Disorders
Metabolic Disorder
Insulin, Isophane
Insulin

Additional relevant MeSH terms:

Hypoglycemic Agents
Metabolic Diseases
Physiological Effects of Drugs
Glargine
Diabetes Mellitus

Endocrine System Diseases
Glucose Metabolism Disorders
Pharmacologic Actions
Insulin

ClinicalTrials.gov processed this record on May 07, 2009