Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.

Launched by LES LABORATOIRES DES MÉDICAMENTS STÉRILES · May 30, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness and safety of a type of insulin called GLARGEN® compared to a different insulin called NPH in people with diabetes in Tunisia. The trial will involve patients who have been using NPH insulin for several years. After a four-week period of continuing their NPH treatment, participants will switch to GLARGEN® insulin for 12 weeks. During this time, their blood sugar levels will be closely monitored using a special device called a continuous glucose monitor (CGM).

To be eligible for this trial, participants need to be between 18 and 70 years old, have type 2 diabetes for 5 to 10 years, and have stable doses of their current insulin and oral diabetes medications. They should also have certain blood sugar levels within a specific range. However, pregnant or breastfeeding women, those with certain eye conditions related to diabetes, and individuals with severe kidney problems, among other criteria, cannot participate. Throughout the trial, participants will receive guidance and support as they adjust to the new insulin treatment and monitor their blood sugar levels.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age≥ 18 and \<70
• • Type 2 diabetic patients, with a duration of NPH between 5 and 10 years.
• • Patients treated with a double dose of NPH insulin with a stable dose of insulin and a stable dose of ADO (oral antidiabetic drugs) for at least 2 months prior to the start of the study.
• • An HbA1c level between 7% and 10%
• • Ability to use a continuous glucose monitoring (CGM) system and cycle blood glucose with the meter.
• • Written informed consent obtained prior to participation in the study.
• Exclusion Criteria:
• • Pregnant and breastfeeding women
• • Patients with active proliferative and/or complicated diabetic retinopathy, treated by photocoagulation or surgically, within 6 months prior to study entry or any other rapidly progressing unstable retinopathy that may require photocoagulation or surgery during the study (plan to perform fundus prior to inclusion).
• • History of insulin glargine hypersensitivity
• • Treatment with systemic, neuroleptic, immunosuppressive and antiretroviral corticosteroids within 3 months prior to study entry and during the study and other treatments, which may significantly affect blood glucose.
• • Severe renal impairment at baseline defined by a \< 30ml/min.
• • Patients on sulfonylurea drugs or glinides or on more than three oral antidiabetic drugs (ODAs)
• • Patients on rapid insulin.
• • Patients Enrolled in Other Clinical Studies
• • Patients who refuse to sign consent.