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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
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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:

U.S. FDA Resources

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

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
Investigators
Study Director: Zuzana Priborska Sanofi
  More Information

No publications provided

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

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

ClinicalTrials.gov processed this record on June 18, 2013