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Insulin Glargine in Type 2 Diabetes Mellitus

NCT00272077 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2009-12-07

No results posted yet for this study

Summary

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.

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Insuline glargine

Sponsors & Collaborators

Principal Investigators

  • PAIZIS GEORGES, MD · Sanofi

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-04-30
Primary Completion
2006-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00272077 on ClinicalTrials.gov