Safety and Effectiveness Study of Insulin Glargine (LANTUS) Initiation and Titration in Patients With Type 2 Diabetes

NCT ID: NCT01127269

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 178 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2013-06-30

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)

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin Glargine

Patients will receive insulin glargine titrated based on standard of care as recommended by the ADA/EASD Consensus Algorithm. Step 1: insulin glargine initiation regimen for insulin naive patients/ Switch to insulin glargine for patient already treated with basal insulin.

Step 2: the insulin dosage of patients will be titrated according to the ADA/EASD Consensus Algorithm.

Group Type: EXPERIMENTAL

INSULIN GLARGINE

Intervention Type: DRUG

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)

Interventions

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)

Intervention Type: DRUG

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

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

Countries

Argentina

Other Identifiers

U1111-1116-9268

Identifier Type: OTHER

Identifier Source: secondary_id

LANTU_L_04980

Identifier Type: -

Identifier Source: org_study_id