A Phase 3 interventional study of Alpha-Lipoic Acid (ALA) and Placebo in Diabetes Mellitus, Type 2 and Insulin Resistance Syndrome, sponsored by Fayoum University. Not yet recruiting at 1 site in Egypt. Open to participants aged 30 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Fayoum University · Phase 3, Interventional, and Treatment
Among 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt — 18 open to participants now, 21 under way, 5 of them phase 3. Diabetes Mellitus, Type 2 · Egypt.
Among the 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt, this one is the 53rd largest by planned enrollment of the 98 interventional ones that give a count, is one of 9 that started in 2026, is one of 15 in phase 3, reaches primary completion later than 15 of the 20 other live ones, and was the 130th registered.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
Browse Diabetes Mellitus, Type 2 studies →18 of the 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt are open now. Recruiting first, the newest first:
New Valley University · Sites in Egypt
Ages 40+ · Healthy volunteers
Mona Mohamed Abdelkhalek · Sites in Egypt
Ages 60–75
Cairo University · Sites in Egypt
Ages 35–45 · Women only
South Valley University · Sites in Egypt
Ages 40–60
Tanta University · Sites in Egypt
Ages 18+
A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →
Of the 883 Diabetes Mellitus, Type 2 studies recruiting now, 373 (42%) set no upper age limit and 384 (43%) stop at 75 or younger; 52 take children under 18; 203 take healthy volunteers.
This study: 30 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
130 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 1 4 · Phase 2 12 · Phase 3 19 · Phase 4 25
First in 2006; this study’s year is marked. 9 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 70 is below the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Median enrollment 80 across the 98 interventional studies, 198 across the 32 observational. Of the 91 that completed or were terminated, 14 (15%) have results posted.
This tab as a report to print or save as PDF → With an account.
26 of 130 have an industry lead sponsor. The 10 most frequent:
Fayoum University is the lead sponsor of 149 studies on the registry; 45 are open to participants now.
Fayoum University has 2 studies filed under Diabetes Mellitus, Type 2 — fewer than ten, so there is no comparison to draw.
4 of the studies in Diabetes Mellitus, Type 2 with a site in Egypt that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07934225Phase 3Fayoum UniversityAlpha-Lipoic Acid Added to Dapagliflozin and Insulin Resistance in Type 2 Diabetes | 2027-08-01 |
| NCT07916428Alexandria UniversityAI-Based Model for Predicting Type 2 Diabetes Risk Using Lifestyle Factors Among Senior Nursing Students | 2026-12 |
| NCT07926074Alexandria UniversityAI Chatbot Mobile App for Self-Management in Type 2 Diabetes | 2027-05-09 |
| NCT07891234Sherihan AboElyazed Mohamed KhalilEffect of SGLT2 Inhibitor on Metabolic-Dysfunction-Associated Fatty Liver Disease in Patients With Insulin Resistance | 2027-10-01 |
Add all 4 to your calendar (.ics) → With an account.
Among the 130 studies in Diabetes Mellitus, Type 2 with a site in Egypt, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The goal of this clinical trial is to test whether adding alpha-lipoic acid (ALA) to usual treatment with metformin and dapagliflozin improves insulin resistance in adults with type 2 diabetes mellitus. The main questions it aims to answer are:
Participants will:
Researchers will compare the ALA group with the placebo group to see if ALA lowers HOMA-IR more than placebo.
Type 2 diabetes mellitus is characterized by insulin resistance. No randomized trial has yet evaluated ALA added to dapagliflozin with HOMA-IR as the primary endpoint, which is the gap this study addresses.
The study is a single-center, parallel-group trial conducted at the Diabetes and Endocrinology Outpatient Clinic of Fayoum University Hospital, Egypt.
Randomization is 1:1 using a computer-generated. Allocation is concealed with sequentially numbered, opaque, sealed envelopes. Capsules are identical in appearance, so participants, treating clinicians, outcome assessors, and the statistician remain blinded until database lock.
Visits take place at baseline, Week 6, and Week 12. Fasting blood samples (glucose, insulin, HbA1c, lipid profile), weight, height, waist circumference, and blood pressure are collected at baseline and Week 12. Week 6 includes anthropometrics, blood pressure, adherence by pill count, and adverse event review. HOMA-IR is calculated as fasting insulin (microunits/mL) multiplied by fasting glucose (mg/dL), divided by 405.
Analysis follows the intention-to-treat principle. Between-group differences are tested with analysis of covariance (ANCOVA) using the baseline value as covariate, with a two-sided significance level of 0.05. The sample size was calculated for a standardized effect size of 0.75 (80% power, alpha 0.05), giving 28 participants per group, increased to allow for 15% dropout and an additional safety margin.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Alpha-lipoic acid 600 mg capsule taken orally once daily for 12 weeks, in addition to the participant's usual metformin and dapagliflozin 10 mg daily, which continue unchanged.
Drug: Alpha-Lipoic Acid (ALA)
Matching placebo capsule taken orally once daily for 12 weeks, in addition to the participant's usual metformin and dapagliflozin 10 mg daily, which continue unchanged.
Drug: Placebo
Oral capsules dispensed at study visits. Unused capsules are returned and counted at Week 6 and Week 12 to measure adherence.
Capsule with no active ingredient, dispensed and counted on the same schedule as the ALA capsule.
Change in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
HOMA-IR = fasting insulin (microunits/mL) x fasting glucose (mg/dL) / 405, calculated from fasting blood samples. Change = Week 12 value minus baseline value.
Time frame: Baseline to Week 12
Change in glycated hemoglobin (HbA1c)
Percentage points, measured by high-performance liquid chromatography. Change = Week 12 minus baseline.
Time frame: Baseline to Week 12
Change in fasting plasma glucose
Measured in mg/dL after 10 to 12 hours of fasting. Change = Week 12 minus baseline.
Time frame: Baseline to Week 12
Change in systolic and diastolic blood pressure
Measured in mmHg. Change = Week 12 minus baseline.
Time frame: Baseline to Week 12
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Aug 2027, 8 months later.
Of 87 non-industry phase 3 interventional studies under Diabetes Mellitus, Type 2, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 47. This study's planned 8 months is below that.
Counting every sponsor, half of 525 studies reached it within 20 months; a quarter within 14 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.