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LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00322075
First received: April 27, 2006
Last updated: September 11, 2007
Last verified: September 2007

April 27, 2006
September 11, 2007
April 2006
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  • 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
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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.

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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
Both
18 Years to 65 Years
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
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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