Status:
NOT_YET_RECRUITING
Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.
Lead Sponsor:
Les Laboratoires des Médicaments Stériles
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief 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 holt...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06999551
Start Date
July 1 2025
End Date
December 31 2025
Last Update
May 31 2025
Active Locations (1)
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1
Hedi Chaker Hospital
Sfax, Tunisia, 3000