LANCGMS - Lantus Continuous Glucose Monitoring Subcutaneous

Phase 4CompletedNCT00322075

Sanofi35 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus

Interventions

insulin glargineDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Sanofi-Aventis

Prague, Czechia

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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