Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration

CompletadoFase 4ClinicalTrials.gov

ID: NCT01127269Tipo: INTERVENTIONALInicio: 1 de may de 2010Fin estimado: 1 de jun de 2013

Traducción no disponible, mostrando original

Resumen

Primary Objective: Percentage of patients achieving Glycosylated Hemoglobin (HbA1c) \< 7% with no severe or nocturnal hypoglycemic episodes at 6 months Secondary Objectives: * Glycosylated Hemoglobin (HbA1c) change from baseline to 6 months * Insulin glargine dose at 3 and 6 months * Hypoglycemic episodes (all types)

Elegibilidad

Edad mínima: 21 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

Patients with a diagnosis of type 2 diabetes for more than 6 months
Patients treated with Oral AntiDiabetics (OADs monotherapy or combination) with an HbA1c \>7% and \<10% and/or treated with NPH insulin with HbA1c \>7% and \<10% or treated with NPH insulin who have experienced severe and/or nocturnal hypoglycemia in the last 6 months.
Ability to perform SMBS and insulin self-titration under the physicians guidance.
Body Mass Index (BMI) \>21 kg/ m2.
Signature of informed consent.

Criterios de exclusión

Hospitalized patients.
Pregnant women or with the intention of becoming pregnant.
Unexplained weight loss of more than 10% in the last 6 months.
Women with child bearing potential not using effective contraceptive methods.
Women in breast feeding period.
Patients on chronic treatment with systemic corticosteroids or protease inhibitors.
History of drug or alcohol abuse.
Diabetic retinopathy with surgical treatment in 3 months previous to study entry or patients that could require surgical treatment in the following 6 months to study entry.
Major systemic disease clinically important that would interfere with implementation or interpretation of the study, at the discretion of the investigator.
Renal failure known as creatinine \> 1.4 mg/dl in women and \> 1.5 mg/dl in men.
Known hypersensitivity to glargine or any of its excipients.
Patients with history of hospitalization due to cardiovascular event, cardiovascular procedure in the past 6 months.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Intervenciones

drug

INSULIN GLARGINE

Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)

Ubicaciones

Investigational Site Number 10

C.a.b.a., Argentina

Investigational Site Number 14

C.a.b.a., Argentina

Investigational Site Number 01

C.a.b.a., Argentina

Investigational Site Number 11

C.a.b.a., Argentina

Investigational Site Number 12

C.a.b.a., Argentina

Investigational Site Number 17

C.a.b.a., Argentina

Investigational Site Number 9

C.a.b.a., Argentina

Investigational Site Number 03

Caba, Argentina

Investigational Site Number 06

Caba, Argentina

Investigational Site Number 15

Caba, Argentina

Investigational Site Number 16

Caba, Argentina

Investigational Site Number 18

Caba, Argentina

Investigational Site Number 26

Capital Federal, Argentina

Investigational Site Number 22

Mar del Plata, Argentina

Investigational Site Number 13

Mar del Plata, Argentina

Investigational Site Number 02

Mar del Plata, Argentina

Investigational Site Number 021

Moreno -Pcia. de Bs. As.-, Argentina

Investigational Site Number 07

Morón, Argentina

Investigational Site Number 04

Paraná, Argentina

Investigational Site Number 8

Salta, Argentina

Investigational Site Number 05

Sarandí, Argentina

Investigational Site Number 20

Tandil, Argentina

Investigational Site Number 25

Zárate, Argentina

Patrocinadores

PrincipalSanofi

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