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

Sanofi

Status and phase: Completed; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: INSULIN GLARGINE

Study type: Interventional

Funder types: Industry

Identifiers

NCT01127269

LANTU_L_04980

U1111-1116-9268 (Other Identifier)

Details and patient eligibility

About

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)

Enrollment: 178 patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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178 participants in 1 patient group

Insulin Glargine

Experimental group

Description:

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.

Treatment:

Drug: INSULIN GLARGINE