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

Study Overview
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Brief Summary
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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)

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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: INSULIN GLARGINE


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Glargine<br>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. | Drug: INSULIN GLARGINE<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Glycosylated Haemoglobin (HbA1c) <7% with no severe documented nocturnal hypoglycemia episode. |  | From week 0 (baseline) to week 24 (end of study) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated Haemoglobin (HbA1c) |  | From week 0 (baseline) to week 24 (end of study) | 
| Dose and timing of insulin glargine |  | From week 0 (baseline) to week 24 (end of study) | 
| Hypoglycemic episodes |  | From week 0 (baseline) to week 24 (end of study) |