None listed
Conditions
Interventions
Group 1 Type of group
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: + insulin glulisine if HbA1c ≥
Group 2 Type of group
Treatment Period 1: Insulin glargine + metformin + other OGLDs, if any Treatment period 2: no change, if HbA1c
Sponsors
sanofi-aventis Recherche & Development,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: • Uncontrolled type 2 diabetes mellitus defined as a HbA1c level between 7.5% and 10% evaluated in the previous 6 months. • Male or female patients 18-75 years old • Body Mass Index (BMI) between 25 and 40 kg / m ^ 2 • Currently treated with basal insulin (NPH, insulin zinc or insulin detemir), plus at least 1g of metformin per day and another OGLD, if present, for at least 3 months • Signed informed consent obtained prior to any study procedure
Exclusion criteria
Exclusion criteria: • Type 1 diabetes mellitus • Active proliferative diabetic retinopathy, defined as the application of photocoagulation or surgery performed within 6 months prior to admission to the study or any other unstable (rapid progression) retinopathy that may require photocoagulation or surgery during the study (confirmed by a fund of eye performed in the previous 2 years) • Cardiovascular, hepatic, neurological, endocrine or other clinically relevant major disease that makes it difficult to implement the protocol or interpretation of the study results. • History of liver function damage defined as Alanine aminotransferase (ALT) and / or Aspartate aminotransferase (AST) greater than three times the upper limit of normal. • History of renal function damage defined as serum creatinine> 135 pmol / l in men and> 110 pmoI / 1 in women • History of drug or alcohol abuse • Patients with DMT2 treated exclusively with OGLD • Patients with DMT2 treated with an insulin other than basal insulin (Premix, rapid insulin, fast-acting insulin analogue) • Previous treatment with insulin glulisine • Concomitant treatment with thiazolidinediones, exenatide or pramlintide • Systemic treatment with corticosteroids within 3 months prior to admission to the study • Treatment with any product under investigation within 2 months prior to admission to the study • History of hypersensitivity to study medications or medications with similar chemical structure • Presence of any mental condition that, in the opinion of the researcher, indicates that participation in the study is not in the best interest of the patient • Presence of geographical or social conditions that restrict or limit patient participation for the duration of the study • Pregnant or breastfeeding women • Women of reproductive age not protected by an effective contraceptive method
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c will be analyzed in the same laboratory for the same patient, with HPLC technique providing a higher normal range below 6.5%, following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine Measure:Change in HbA1c level for patients with addition of glulisine at week 12 Timepoints:week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:HbA1c will be analyzed in the same laboratory for the same patient, with HPLC technique providing a higher normal range below 6.5%, following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine Measure:Percentage of patients with HbA1c level < 7% Timepoints:Durante el estudio ; Outcome name:HbA1c will be analyzed in the same laboratory for the same patient, with HPLC technique providing a higher normal range below 6.5%, following the reference of the International Federation of Clinical Chemistry and Laboratory Medicine Measure:Percentage of patients with HbA1c level < 7% and no symptomatic nocturnal hypoglycemia event Timepoints:During the study ; Outcome name:Through laboratory tests performed during the study. Measure:Changes in Fasting Plasma Glucose Timepoints:at week 0, week 12 and week 24 ; Outcome name:the daily dose (U) and daily dose / kg (U / kg) will be calculated at week 24. Measure:Change in the Dose of insulin glargine and insulin glulisine Timepoints:week 24. | — |
Countries
Arabia Saudi, Argeria, Brazil, Israel, Lebano, Mexico, Morocco, Peru, United Arab Emirates, Venezuela
Contacts
Public ContactPablo Antonio Acevedo
SANOFI AVENTIS DEL PERU S.A.
Outcome results
None listed