Ignite Creation Date:
2025-12-25 @ 1:01 AM
Ignite Modification Date:
2026-01-03 @ 4:11 AM
Study NCT ID:
NCT05369793
Status:
COMPLETED
Last Update Posted:
2023-11-22
First Post:
2022-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003929', 'term': 'Diabetic Neuropathies'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D006943', 'term': 'Hyperglycemia'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008063', 'term': 'Thioctic Acid'}, {'id': 'C424423', 'term': 'Roflumilast'}], 'ancestors': [{'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-20', 'studyFirstSubmitDate': '2022-05-06', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2023-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': "Assessment of changes in patients' quality of life", 'timeFrame': 'baseline and 3 months later', 'description': 'Using Diabetes Quality Of Life questionnaire (DQOL)'}, {'measure': 'Major adverse cardiovascular events (MACE)', 'timeFrame': '3 months', 'description': 'Major adverse cardiovascular events (MACE) as non-fatal myocardial infarction (MI), non-fatal stroke, and cardiovascular death.'}], 'primaryOutcomes': [{'measure': 'Change in fasting blood glucose', 'timeFrame': 'baseline and 3 months later', 'description': 'Using glucose oxidase method for assessment of blood glucose and subtracting pre-treatment from post-treatment values'}, {'measure': 'Change in plasma insulin level', 'timeFrame': 'baseline and 3 months later', 'description': 'Subtracting pre-treatment from post-treatment values of plasma insulin'}, {'measure': 'Change in HOMA-IR index', 'timeFrame': 'baseline and 3 months later', 'description': 'HOMA-IR will be calculated for all patients at baseline and 3 months later.'}, {'measure': 'Change in HOMA-B index', 'timeFrame': 'baseline and 3 months later.', 'description': 'HOMA-B will be calculated for all patients at baseline and 3 months later.'}, {'measure': 'Change in HbA1c', 'timeFrame': 'baseline and 3 months later', 'description': 'Subtracting pre-treatment from post-treatment values of HbA1C'}], 'secondaryOutcomes': [{'measure': 'Changes in TNF-alfa serum level', 'timeFrame': 'baseline and 3 months later', 'description': 'Subtracting pre-treatment from post-treatment values of TNF-alfa.'}, {'measure': 'Changes in malondialdehyde serum level (MDA)', 'timeFrame': 'baseline and 3 months later', 'description': 'Subtracting pre-treatment from post-treatment values of MDA.'}, {'measure': 'Changes in neurotensin serum levels', 'timeFrame': 'baseline and 3 months later', 'description': 'Subtracting pre-treatment from post-treatment values of neurotensin serum levels.'}, {'measure': 'Ewing score', 'timeFrame': 'baseline and 3 months later', 'description': '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.'}, {'measure': 'Changes of Michigan Neuropathy Screening Instrument', 'timeFrame': 'baseline and 3 months later', 'description': "A 15-item questionnaire (MNSIQ) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.\n\nMNSIQ 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."}, {'measure': 'Changes of Michigan Neuropathy Screening Instrument(MNSIE)', 'timeFrame': 'baseline and 3 months later', 'description': "A foot test (MNSIE) is used to assess deformation, infection, skin thickening of the skin's stratum corneum, and ulcers.\n\nMNSIE 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."}, {'measure': 'Changes of Douleur Neuropathique-4 (DN4) questionnaire (DN4)', 'timeFrame': 'baseline and 3 months later', 'description': 'DN4 Neuropathic Pain Diagnostic Questionnaire which reflect positive symptoms for pain ( burning, painful cold, electric shocks, )'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'diabetic neuropathy', 'hyperglycemia'], 'conditions': ['Type 2 Diabetes (Adult Onset)', 'Diabetic Neuropathies']}, 'referencesModule': {'references': [{'pmid': '41256904', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with a diagnosis of type 2 diabetes mellitus (T2DM).\n* HbA1c at baseline: ≥7.5 % to 8.5 %.\n* BMI between ≥26 and ≤35 kg/ m2.\n* Established Diabetic neuropathy diagnosed by nerve conduction study (NCS).\n\nExclusion Criteria:\n\n* Patients diagnosed with type 1 diabetes mellitus or diabetes secondary to pancreatitis or resection of the pancreas.\n* Patients diagnosed with hemoglobinopathies, hemolytic anemia, or other diseases which interfere with HbA1c measurement.\n* Thyroid disease, cardiovascular disease, peripheral vascular disease, coagulopathy, moderate to severe liver disease (bilirubin\\>1.5mg), or renal excretion ≤90ml/min.\n* 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.)\n* Treatment with any diabetes medications other than glimepiride prior to intervention.\n* 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.\n* Patients with morbid obesity (BMI ≥ 40 kg/ m2).\n* History or current diagnosis of major depressive disorders or other psychiatric disorders.\n* Pregnant and breastfeeding women.\n* Patients with any inflammatory diseases.\n* Patients on cytochrome P450 inducers (e.g., rifampicin, phenobarbital, carbamazepine, phenytoin, etc.).\n* Patients with Low vitamin B12 levels according to suggested normal values for T2DM patients over 60 years old (\\<400 pmol/L).'}, 'identificationModule': {'nctId': 'NCT05369793', 'briefTitle': 'Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Clinical Study Evaluating the Safety and Efficacy of Roflumilast in Type 2 Diabetic Patients With Diabetic Neuropathy', 'orgStudyIdInfo': {'id': '35420/4/22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Alpha-lipoic acid arm', 'description': 'Administration of alpha-lipoic acid 600 mg orally once daily for 3 months.', 'interventionNames': ['Drug: Alpha lipoic acid']}, {'type': 'EXPERIMENTAL', 'label': 'Roflumilast arm', 'description': 'Administration of roflumilast 500 mcg orally once daily for 3 months.', 'interventionNames': ['Drug: Roflumilast']}], 'interventions': [{'name': 'Alpha lipoic acid', 'type': 'DRUG', 'description': 'Administration of alpha-lipoic acid 600mg plus vildagliptin/metformin combination (50/1000mg) orally once daily for 3 months.', 'armGroupLabels': ['Alpha-lipoic acid arm']}, {'name': 'Roflumilast', 'type': 'DRUG', 'description': 'Administration of 500 mcg plus vildagliptin/metformin combination(50/1000mg) orally once daily for 3 months.', 'armGroupLabels': ['Roflumilast arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31511', 'city': 'Tanta', 'country': 'Egypt', 'facility': 'Asmaa Elshafey Elsharab', 'geoPoint': {'lat': 30.78847, 'lon': 31.00192}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanta University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharm D', 'investigatorFullName': 'Asmaa Elshafey Elsharab', 'investigatorAffiliation': 'Tanta University'}}}}