Switching Diabetes Patients in Tunisia From NPH to Glargine Insulin
Tests switching adults with type 2 diabetes from NPH insulin to glargine insulin.
Plain-language title generated from the registry record
Registry title: Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.
Key facts
- Where
- Sfax, TunisiaSee the site
- Phase
- Phase 4
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with type 2 diabetes who have used NPH insulin for 5 to 10 years. Everyone switches from NPH to insulin glargine (Glargen) for 12 weeks.
- Age
- 18 to under 70 years
- Sex
- All sexes
- Disease stage
- Type 2 diabetes with an HbA1c level between 7% (53 mmol/mol) and 10% (86 mmol/mol).
- Earlier treatment
- Must have used NPH insulin for 5 to 10 years, at a stable dose, twice a day. Oral diabetes medicines must also be at a stable dose for at least 2 months before the start.
- Biomarker or test result
- HbA1c between 7% (53 mmol/mol) and 10% (86 mmol/mol).
Main reasons for not taking part
- Pregnant or breastfeeding women
- Serious eye damage from diabetes that needed laser or surgery in the past 6 months
- Allergy to insulin glargine
- Severe kidney problems (below 30 ml/min)
- Use of sulfonylurea or glinide drugs, more than three oral diabetes drugs, or rapid insulin
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06999551, who can take part
Where in Tunisia
- Hedi Chaker HospitalSfax, TunisiaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Les Laboratoires des Médicaments Stériles
- Trial code
- NCT06999551
- Record updated
- 31 May 2025
- Original description
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.Read full original descriptionShow less
Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in the Treatment of Diabetes Type 2, in Tunisian Patients.
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
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: 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); History of insulin glargine hypersensitivity; Severe renal impairment at baseline defined by a < 30ml/min; 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; Pregnant and breastfeeding women; Patients on rapid insulin; Patients Enrolled in Other Clinical Studies; Patients who refuse to sign consent.