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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
April 27, 2006
May 4, 2006
September 12, 2007
April 2006
Not Provided
  • 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
Not Provided
Complete list of historical versions of study NCT00322075 on ClinicalTrials.gov Archive Site
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LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous
Comparison of Glycaemic Fluctuations During 3 Days Subcutaneous Continuous Monitoring in Patients With Basal Substitution Human Insulin NPH vs Insuline Glargine
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.
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Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus
Drug: insulin glargine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
November 2006
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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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT00322075
LANTU_L_00722
EudraCT # : 2006-000122-31
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Sanofi
Not Provided
Study Director: Zuzana Priborska Sanofi
Sanofi
September 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP