Trial · NCT05369793
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
NCT05369793, Phase 3, Completed, Tanta University
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy. Trials, record NCT05369793. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05369793
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
- NCT number
- NCT05369793
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 60 participants, actual
- Lead sponsor
- Tanta University
- Conditions
- Type 2 Diabetes (Adult Onset), Diabetic Neuropathies
- Interventions
- Alpha lipoic acid, Roflumilast
- First posted
- 2022-05-11
- Last updated
- 2023-11-22
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in fasting blood glucose | baseline and 3 months later | Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values |
| Primary | Change in plasma insulin level | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of plasma insulin |
| Primary | Change in HOMA-IR index | baseline and 3 months later | HOMA-IR will be calculated for all patients at baseline and 3 months later. |
| Primary | Change in HOMA-B index | baseline and 3 months later. | HOMA-B will be calculated for all patients at baseline and 3 months later. |
| Primary | Change in HbA1c | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of HbA1C |
| Secondary | Changes in TNF-alfa serum level | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of TNF-alfa. |
| Secondary | Changes in malondialdehyde serum level (MDA) | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of MDA. |
| Secondary | Changes in neurotensin serum levels | baseline and 3 months later | Subtracting pre-treatment from post-treatment values of neurotensin serum levels. |
| Secondary | Ewing score | baseline and 3 months later | 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. |
| Secondary | Changes of Michigan Neuropathy Screening Instrument | baseline and 3 months later | 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. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41256904 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05369793
GET https://conductscience.org/api/trials/v1/NCT05369793/registered