NCT06999551

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

Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Les Laboratoires des Médicaments Stériles · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study will have a single arm: the patient on NPH will continue his treatment for 4 weeks, at the end of the NPH treatment, the patient will receive his CGM device for three days for glycemic holter, a switch to insulin glargine is started for a period of 12 weeks with a dose adjustment and a control of the glycemic balance by CGM for three days at the end of the study. The NPH insulin vial is a 10 ml vial dosed at 100 IU/mL, The Glargen vial is in the form of a solution for injection, a 3 ml vial dosed at 100 IU/mL

Detailed description

Follow-up visits will include : * V0: - 4 weeks: Screening visit (before the start of treatment): patients will be selected at this initial visit, if they meet all the inclusion criteria and none of the non-inclusion criteria, the patient will receive the glucometer. The patient presents himself to do his initial assessment (including HbA1c) and sign the consent, to do his therapeutic education and to receive the nutrition booklet * V1: -3 weeks: the patient will be contacted by the ARC (phone call) to communicate the results of the glycemic cycle already performed and for titration of his NPH, continue with the new dose until the monitoring stops * V2: inclusion visit: D0: 4 weeks later, the patient will receive his CGM. A glycemic cycle will be done and communicated to the ARC. * V3: Visit of 4 weeks + 07 days: the day the patient presents himself to put the CGM device back on (stop monitoring) and collect data (glycemic holter under NPH) and switch to insulin glargine. * V4 + V5: respectively at 2 and 3 weeks after switching to insulin glargine, the CRA contacts the patient by phone to record the results of the glycemic cycle and thus adapt the dose of insulin glargine upwards or downwards as needed (titration). The patient will do a glycemic cycle and communicate it to their ARC. Continue with the new dose until the next V6 titration * V6: at 6 weeks after switching to insulin glargine, the patient will attend the consultation (face-to-face) to communicate the results of the corresponding glycemic cycle and thus adapt the dose of insulin glargine upwards or downwards as needed (titration). Continue with the new dose until monitoring is stopped * V7: 12 weeks after starting glargine, the patient presents again for placement of the CGM device (start of monitoring). The patient will also do a glycemic cycle at the same time and communicate it to his ARC. A laboratory assessment (including glycated hemoglobin) will be requested. * V8: 12 weeks + 7 days stop CGM monitoring (collection of holter results under glargine) and end of the study.

Conditions

• Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	switch NPH to glargin	Switch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine

Timeline

• Start date: 2025-07-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2025-05-31
• Last updated: 2025-05-31

Locations

1 site across 1 country: Tunisia