Type 2 Diabetes (Adult Onset)Phase 3NCT05369793
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
A Phase 3 study testing Alpha lipoic acid and Roflumilast in people with Type 2 Diabetes (Adult Onset) and Diabetic Neuropathies, run by Tanta University at 1 site in Egypt.
Trial summary
Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Type 2 Diabetes (Adult Onset), Diabetic Neuropathies
- What is being tested?
- Alpha lipoic acid and Roflumilast
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2022to 10 Oct 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a diagnosis of type 2 diabetes mellitus (T2DM).
- HbA1c at baseline: ≥7.5 % to 8.5 %.
- BMI between ≥26 and ≤35 kg/ m2.
- Established Diabetic neuropathy diagnosed by nerve conduction study (NCS).
Who cannot join
- Patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas.
- Patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with HbA1c measurement.
- Thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin>1.5mg), or renal excretion ≤90ml/min.
- Patients on medications which can result in a change of weight (orlistat, metformin, clozapine, gabapentin) and patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, non-selective β-blockers, thiazides, etc.)
- Treatment with any diabetes medications other than glimepiride prior to intervention.
- Clinically significant cardiac abnormalities (diagnosed clinically, history, or by X-ray/ECG) that were not related to type 2 diabetes mellitus and that required further evaluation.
Show all 12Show fewer
- Patients with morbid obesity (BMI ≥ 40 kg/ m2).
- History or current diagnosis of major depressive disorders or other psychiatric disorders.
- Pregnant and breastfeeding women.
- Patients with any inflammatory diseases.
- Patients on cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, etc.).
- Patients with Low vitamin B12 levels according to suggested normal values for T2DM patients over 60 years old (<400 pmol/L).
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy.
- Being tested
- Alpha lipoic acid, Roflumilast
- Keywords
- diabetes mellitus, diabetic neuropathy, hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Neuropathies, Diabetes Mellitus, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alpha lipoic acidDrug
Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.
RoflumilastDrug
Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Alpha-lipoic acid arm | Active comparator | Administration of alpha-lipoic acid 600 mg orally once daily for 3 months. Receives: Drug: Alpha lipoic acid |
| Roflumilast arm | Experimental | Administration of roflumilast 500 mcg orally once daily for 3 months. Receives: Drug: Roflumilast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fasting blood glucose
Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values
Measured: baseline and 3 months later
Change in plasma insulin level
Subtracting pre-treatment from post-treatment values of plasma insulin
Measured: baseline and 3 months later
Change in HOMA-IR index
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Measured: baseline and 3 months later
Change in HOMA-B index
HOMA-B will be calculated for all patients at baseline and 3 months later.
Measured: baseline and 3 months later.
Change in HbA1c
Subtracting pre-treatment from post-treatment values of HbA1C
Measured: baseline and 3 months later
Secondary outcomes (7)
Changes in TNF-alfa serum level
Subtracting pre-treatment from post-treatment values of TNF-alfa.
Measured: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
Subtracting pre-treatment from post-treatment values of MDA.
Measured: baseline and 3 months later
Changes in neurotensin serum levels
Subtracting pre-treatment from post-treatment values of neurotensin serum levels.
Measured: baseline and 3 months later
Ewing score
Subtracting pre-treatment from post-treatment changes in summation of the cardiac autonomic reflex tests (CARTs) including heart response to a deep breathing test, changes in immediate heart rate response to standing, and changes in blood pressure response to sustained handgrip testing.
Measured: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument
A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.
MNSIQ was designed to screen for diabetic neuropathy through questionnaires on 15 questions that are related to neuropathic symptoms (pain, temperature, and sensation). Two of 15 (number 4 and 10) are vascular symptoms and are excluded from the total score regardless of the results. If you answered 'No' to questions 7 and 13, you will get 1 point. In the end, scores ranging from 0 to 13 indicate that the higher the score, the more severe the neuropathic symptoms.
Measured: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument(MNSIE)
A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.
MNSIE evaluates foot shape, foot ulceration, ankle reflex, sense of vibration of big toe, monofilament right and left. The score ranges from point 0 to 10, and when the score is above 2, it is diagnosed as neuropathy.
Measured: baseline and 3 months later
Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)
DN4 Neuropathic Pain Diagnostic Questionnaire which reflect positive symptoms for pain ( burning, painful cold, electric shocks, )
Measured: baseline and 3 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start1 Aug 2022
- Primary completion10 Oct 2023
- Study completion10 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes (Adult Onset)Studies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Elshafey Elsharab, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369793
- Sponsor's protocol ID
- 35420/4/22
- Status last verified
- Nov 2023
- First submitted
- 6 May 2022
- Last updated
- 22 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elsharab A, Nooh MZ, Matard RS, Mostafa TM, El-Afify DR. Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study. Diabetes Metab Syndr Obes. 2025 Nov 13;18:4193-4210. doi: 10.2147/DMSO.S548285. eCollection 2025.
PubMed 41256904
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
- ClinicalTrials.gov ID
- NCT05369793
- Acronym / sponsor ID
- 35420/4/22
- Keywords
- diabetes mellitus, diabetic neuropathy, hyperglycemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 10 Oct 2023 (actual)
- First posted
- 11 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the side effects and efficacy of roflumilast on glycemic parameters, insulin resistance, oxidative and inflammatory markers in Type 2 diabetic patients with diabetic neuropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alpha-lipoic acid arm | Active comparator | Drug: Alpha lipoic acidAdministration of alpha-lipoic acid 600 mg orally once daily for 3 months. |
| Roflumilast arm | Experimental | Drug: RoflumilastAdministration of roflumilast 500 mcg orally once daily for 3 months. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with a diagnosis of type 2 diabetes mellitus (T2DM).
- HbA1c at baseline: ≥7.5 % to 8.5 %.
- BMI between ≥26 and ≤35 kg/ m2.
- Established Diabetic neuropathy diagnosed by nerve conduction study (NCS).
Key exclusion criteria (12 listed)
- Patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas.
- Patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with HbA1c measurement.
- Thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin>1.5mg), or renal excretion ≤90ml/min.
- Patients on medications which can result in a change of weight (orlistat, metformin, clozapine, gabapentin) and patients on medications that can interfere with glucose or lipid metabolism (corticosteroids, non-selective β-blockers, thiazides, etc.)
- Treatment with any diabetes medications other than glimepiride prior to intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alpha lipoic acidAdministration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months. | Drug | Alpha-lipoic acid arm |
| RoflumilastAdministration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months. | Drug | Roflumilast arm |
Primary outcome
Change in fasting blood glucose
Time frame: baseline and 3 months later
Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values
Change in plasma insulin level
Time frame: baseline and 3 months later
Subtracting pre-treatment from post-treatment values of plasma insulin
Change in HOMA-IR index
Time frame: baseline and 3 months later
HOMA-IR will be calculated for all patients at baseline and 3 months later.
Change in HOMA-B index
Time frame: baseline and 3 months later.
HOMA-B will be calculated for all patients at baseline and 3 months later.
Change in HbA1c
Time frame: baseline and 3 months later
Subtracting pre-treatment from post-treatment values of HbA1C
7 secondary outcomes
Changes in TNF-alfa serum level
Time frame: baseline and 3 months later
Changes in malondialdehyde serum level (MDA)
Time frame: baseline and 3 months later
Changes in neurotensin serum levels
Time frame: baseline and 3 months later
Ewing score
Time frame: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument
Time frame: baseline and 3 months later
Changes of Michigan Neuropathy Screening Instrument(MNSIE)
Time frame: baseline and 3 months later
Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)
Time frame: baseline and 3 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2023.
- Derived from this study: PubMed 41256904Elsharab A, Nooh MZ, Matard RS, Mostafa TM, El-Afify DR. Efficacy and Safety of Roflumilast versus Alpha-Lipoic Acid in Type 2 Diabetes with Neuropathy: A Comparative Clinical Study. Diabetes Metab Syndr Obes. 2025 Nov 13;18:4193-4210. doi: 10.2147/DMSO.S548285. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Type 2 Diabetes (Adult Onset)
Recruiting
Differentiating Heart Disease Between Adult-onset Autoimmune and Type 2 Diabetes
Diabete Mellitus, Autoimmune Diabetes
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
ENLIGHT Trial: ESG With Fundal Mucosal Ablation
Obesity, Obesity (Body Mass Index >30 kg/m2)
Recruiting
Hydration Intervention to Decrease Side Effects Associated With GLP - 1 RA Therapy
Obesity & Overweight, Type 2 Diabetes
Recruiting
OBESIAL: A Prospective Interventional Real-world Study of a Multidisciplinary Obesity Management Programme
Obesity Difficult Airway Airway Management, Obesity Adult Onset
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alpha lipoic acid and Roflumilast in people with Type 2 Diabetes (Adult Onset) and Diabetic Neuropathies, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fasting blood glucose (time frame: baseline and 3 months later). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05369793, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2023.