EFFICACY AND SAFETY OF INTENSIVE INSULIN THERAPY WITH INSULIN GLULISINE IN PATIENTS WITH TYPE 2 DIABETES INADEQUATELY CONTROLLED WITH BASAL INSULIN AND ORAL GLUCOSE-LOWERING DRUGS

Not Applicable

Completed

• Conditions: -E11 Non-insulin-dependent diabetes mellitus; Non-insulin-dependent diabetes mellitus; E11

• Registration Number: PER-119-10
• Lead Sponsor: sanofi-aventis Recherche & Development,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02-21
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

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

• 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br>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<br>Measure:Change in HbA1c level for patients with addition of glulisine at week 12<br>Timepoints:week 12<br>