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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00272077 |
Primary objective:
To evaluate in explorative manner the fasting blood glucose (FBG) coefficient of variability (CV)calculated on SMBG values (SMBG : Self-Monitoring of Blood Glucose).
Secondary objectives:
The secondary objectives are the assessment of: changes in glycaemic control (HbA1C), frequency of hypoglycaemias, changes in weight, final insulin dose, changes in lipid parameters, changes in urinary albumin-to-creatinine ratio, profile of patient which best fits each of the algorithms with the dependent variable of change in HbA1C and independent variables of age, gender, race, tobacco use, diabetes complications, initial HbA1C, initial weight, duration of diabetes mellitus, general education and diabetes education.
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: Insuline glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study on Glycaemic Variability in Type 2 Diabetes Mellitus Patients With Basal Insulin and Fixed Combo Oral Antidiabetic Treatment. |
Study Start Date: | April 2005 |
Primary Completion Date: | May 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 45 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion criteria:
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HOE901/3509, EudraCT # : 2004-002730-19 |
Study First Received: | January 2, 2006 |
Last Updated: | August 5, 2008 |
ClinicalTrials.gov Identifier: | NCT00272077 |
Health Authority: | Italy: Ministry of Health |
Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Endocrine System Diseases |
Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |