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

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin, Globin Zinc

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.