NCT06999551Not yet recruitingPhase 4
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.
Source: ClinicalTrials.gov · Last updated 31 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 7 Mar 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Les Laboratoires des Médicaments Stériles
- Diseases
- Type 2 diabetes
- NCT number
- NCT06999551
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 60
- From 1 Jul 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Patients on sulfonylurea drugs or glinides or on more than three oral antidiabetic drugs (ODAs)
Other illness
- History of insulin glargine hypersensitivity
- Severe renal impairment at baseline defined by a \< 30ml/min.
Lab values
- 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.
Other
- Pregnant and breastfeeding women
- Patients on rapid insulin.
- Patients Enrolled in Other Clinical Studies
- Patients who refuse to sign consent.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hedi Chaker Hospital Coordinator of this site? Confirm its status | Sfax | Tunisia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.