Clinical trial NCT01127269: Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes
Official title: Practical Implementation of ADA/EASD Consensus Algorithm in Patients With Type 2 Diabetes: Timely Insulin Initiation and Titration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-05-20
Enrollment: 178
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion criteria:

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode.
timeFrame: From week 0 (baseline) to week 24 (end of study)
Secondary outcomes:
measure: Glycosylated Haemoglobin (HbA1c)
timeFrame: From week 0 (baseline) to week 24 (end of study)
measure: Dose and timing of insulin glargine
timeFrame: From week 0 (baseline) to week 24 (end of study)
measure: Hypoglycemic episodes
timeFrame: From week 0 (baseline) to week 24 (end of study)
Other outcomes:
Locations:
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 10
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 14
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 01
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 11
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 12
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 17
city: C.a.b.a.
country: Argentina
facility: Investigational Site Number 9
city: Caba
country: Argentina
facility: Investigational Site Number 03
city: Caba
country: Argentina
facility: Investigational Site Number 06
city: Caba
country: Argentina
facility: Investigational Site Number 15
city: Caba
country: Argentina
facility: Investigational Site Number 16
city: Caba
country: Argentina
facility: Investigational Site Number 18
city: Capital Federal
country: Argentina
facility: Investigational Site Number 26
city: Mar del Plata
country: Argentina
facility: Investigational Site Number 22
city: Mar del Plata
country: Argentina
facility: Investigational Site Number 13
city: Mar del Plata
country: Argentina
facility: Investigational Site Number 02
city: Moreno -Pcia. de Bs. As.-
country: Argentina
facility: Investigational Site Number 021
city: Morón
country: Argentina
facility: Investigational Site Number 07
city: Paraná
country: Argentina
facility: Investigational Site Number 04
city: Salta
country: Argentina
facility: Investigational Site Number 8
city: Sarandí
country: Argentina
facility: Investigational Site Number 05
city: Tandil
country: Argentina
facility: Investigational Site Number 20
city: Zárate
country: Argentina
facility: Investigational Site Number 25
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: