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

NCT06999551 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-31

No results posted yet for this study

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

Conditions

Interventions

DRUG

switch NPH to glargin

Switch of patients with type 2 diabetes mellitus from NPH insulin to insulin glargine

Sponsors & Collaborators

  • Les Laboratoires des Médicaments Stériles

    lead INDUSTRY

Principal Investigators

  • Nabila Rekik, Professor · STEDIAM

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-01
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Tunisia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06999551 on ClinicalTrials.gov