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LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00322075
First Posted: May 4, 2006
Last Update Posted: September 12, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  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 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine

Resource links provided by NLM:


Further study details as provided by Sanofi:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322075


Locations
Czech Republic
Sanofi-Aventis
Prague, Czech Republic
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Zuzana Priborska Sanofi
  More Information

ClinicalTrials.gov Identifier: NCT00322075     History of Changes
Other Study ID Numbers: LANTU_L_00722
EudraCT # : 2006-000122-31
First Submitted: April 27, 2006
First Posted: May 4, 2006
Last Update Posted: September 12, 2007
Last Verified: September 2007

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs