Not yet taking people in TunisiaPhase 4

Switching Diabetes Patients in Tunisia From NPH to Glargine Insulin

Tests switching adults with type 2 diabetes from NPH insulin to glargine insulin.

Key facts

Who runs it: Les Laboratoires des Médicaments Stériles
Where: Sfax, TunisiaSee the site
Trial code: NCT06999551
Registry title: Comparison of the Efficacy and Safety of GLARGEN® Versus NPH Insulin in Diabetic Tunisian Patients.
Status: Not yet recruiting
Phase: Phase 4
People taking part: 60 people, planned
Started: 1 Jul 2025
Planned end: 31 Dec 2025
Type of study: Interventional
Treatments tested: switch NPH to glargin
Record updated: 31 May 2025

Who can take part

AI summary

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

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

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

Who cannot take part

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

Check if you might fit

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?

Where in Tunisia

Hedi Chaker HospitalSfax, TunisiaContact: Nabila Rekik, ProfessorNo longer taking part

About the trial

What the trial wants to find out

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

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

The group in the trial

patient receiving NPH insulinTreatment being tested
evaluating safety and efficacy after switching the patient receiving NPH into glargin insulin.
Treatment: switch NPH to glargin