Diabetes Mellitus, Type 2
Conditions
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)
Interventions
DRUGINSULIN 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)
Sponsors
Sanofi
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| Hypoglycemic episodes | From week 0 (baseline) to week 24 (end of study) |
| 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) |
Countries
Argentina
Outcome results
None listed