A Phase 2/3 interventional study of Atherolive and Placebo Atherolive in Diabetes Mellitus, Type 2, sponsored by University of Monastir. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-06-03.
Sponsored by University of Monastir · Phase 2/3, Interventional, and Prevention
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Among 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia — 2 open to participants now, 2 under way, 1 of them phase 3. Diabetes Mellitus, Type 2 · Tunisia.
Among the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia, this one is the 8th largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2023, is one of 2 in phase 2/3, and was the 15th registered.
10,378 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,410 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →2 of the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia are open now. Recruiting first, the newest first:
University Tunis El Manar · Sites in Tunisia
Ages 18–65
A study can be open while its sites in Tunisia have not opened yet or have stopped. Only those recruiting at a site in Tunisia →
Of the 882 Diabetes Mellitus, Type 2 studies recruiting now, 374 (42%) set no upper age limit and 383 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 18 Years to 100 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 8 · Phase 4 5
First in 2008; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 500 is above the median of 80 across 8,356 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 519 across the 14 interventional studies, 10,145 across the 5 observational. Of the 16 that completed or were terminated, 7 (44%) have results posted.
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13 of 19 have an industry lead sponsor. The 10 most frequent:
University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
University of Monastir has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
1 of the studies in Diabetes Mellitus, Type 2 with a site in Tunisia that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07467967University Tunis El ManarImpact of Date Consumption on Metabolic Control and Oxidative Stress in Patients With Type 2 Diabetes | 2027-02-20 |
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Among the 19 studies in Diabetes Mellitus, Type 2 with a site in Tunisia, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This study will be carried out in 2 emergency departments (at the exit of the emergency room) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
Patients over 18 years of age with:
-Diabets
This study will be carried out in 2 emergency departments (at the exit of the emergency room, patients included in the GR2 study) and 2 external consultations (endocrinology of the CHU FB Monastir and diabetology consultation, Jemmal hospital).
All the population will benifit of a biological assessment which include:
Continuous blood glucose monitoring to measure indices of glycemic variability is performed at baseline. These patients will be equipped with an iPro continuous glycemic monitoring
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Exclusion Criteria:
In this Arm the patient will receive the study drug (atherol) that will be prescribed at a dose of 400 mg, once a day for 3 months.
Drug: Atherolive
In this Arm patients will receive the placebo at a dose of 400 mg once a day for 3 months.
Drug: Placebo Atherolive
The patient will be assigned using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The study drug (atherol) will be prescribed at a dose of 400 mg, once a day for 3 months.
The patient will be assigned using a computer-generated randomization list (1: 1 allocation). The investigator who has the randomization code is not involved in other study procedures and does not interact with participants. The placebo will be prescribed at a dose of 400 mg once a day for 3 months.
rate of continuous glycemic monitoring and Hemoglobin A1C
Patients will be fitted with an iPro continuous glycemic monitoring (CGM) recorder (Medtronic, Northridge, CA) for 24 consecutive hours on an outpatient basis . A CGM (Enlite Sensor) sensor is inserted into abdominal (or arm) fatty tissue subcutaneously and calibrated according to Medtronic standard operating guidelines. The iPro Continuous Glucose Recorder measures interstitial subcutaneous tissue glucose levels continuously, recording values every 5 minutes, over a range of 40-400 mg/dL.recorded data will be downloaded for analysis of glucose profile and glucose excursion parameters with the CareLink iPro system. Analysis will be performed on the data obtained within the 24-hour period after placement.
Time frame: 90 days
variation in lipid balance
Rate of variation in lipid balance
Time frame: 90 days
rate of hospitalization for cardiovascular disease and adverse effects
, rate of hospitalization for cardiovascular disease : acute infarction, hypertension, acute stroke as well as number of adeverse events reported
Time frame: 90 days
Started Jan 2023 (actual). Primary completion is estimated for Sep 2025, 32 months after the start.
Of 26 non-industry phase 2/3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's planned 32 months is above that.
Counting every sponsor, half of 32 studies reached it within 22 months; a quarter within 13 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
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