Ignite Creation Date:
2025-12-24 @ 10:54 PM
Ignite Modification Date:
2026-02-25 @ 8:25 PM
Study NCT ID:
NCT01895569
Status:
UNKNOWN
Last Update Posted:
2013-07-10
First Post:
2013-06-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Triple Therapy in Type 2 Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}, {'id': 'D000077205', 'term': 'Pioglitazone'}, {'id': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 64}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-07-03', 'studyFirstSubmitDate': '2013-06-30', 'studyFirstSubmitQcDate': '2013-07-03', 'lastUpdatePostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Insulin-resistance parameters', 'timeFrame': '9 months', 'description': 'Insulin-resistance parameters will be assessed using HOMA-index (HOMA-IR and HOMA-β).'}], 'primaryOutcomes': [{'measure': 'Glycemic variability', 'timeFrame': '9 months', 'description': 'Glycemic variability will be assessed at the baseline, and every three months, using a continuous glucose monitoring system.'}], 'secondaryOutcomes': [{'measure': 'Glyco-metabolic control', 'timeFrame': '9 months', 'description': 'Glyco-metabolic control will be assessed evaluating glycated hemoglobin, fasting plasma glucose and post-prandial glucose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The treatment of type 2 diabetes mellitus often requires the use of one or more hypoglycemic agents to reach the adequate glycemic control. The aim of the study is to evaluate the effects of a triple therapy with metformin, pioglitazone and sitagliptin on glycemic variability compared to metformin monotherapy, and compared to a combination of metformin and pioglitazone. To assess glycemic variability a continuous glucose monitoring system will be used.', 'detailedDescription': 'In an estimated temporal space of about 3 years, 64 not well controlled, type 2 diabetic patients will be recruited.\n\nPatients will be instructed to take metformin 500 mg three times a day for the first three months, then pioglitazone 15 mg twice a day will be added for further three months, and finally sitagliptin 100 mg once a day will be added for the last three months. At the baseline, and every three months a continuous glucose monitoring system will be performed.\n\nAt any stage of the study, if the value of glycated hemoglobin reach the desired goal (\\<6.5%), participation in the study will be stopped and the patient will not be subjected to further adjustments of hypoglycemic therapy or additional continuous monitoring glucose.\n\nAfter collection of written informed consent, the following data will be collected:\n\n* History: type of diabetes, comorbidities, current medication, duration of diabetes and complications, voluptuary habits such as tobacco smoke (both number of packets/year and n° packets/day), alcohol consumption, coffee consumption, physical activity.\n* Physical exam, general anthropometric parameters such as weight, height, circumference, body mass index, waist-hip ratio, and blood pressure.\n* Assessment of glycemic variability every three months using a continuous glucose monitoring system.\n* Collection of blood and urine samples to assess: glycated hemoglobin, fasting plasma glucose (FPG), post-prandial glucose (PPG), fasting plasma insulin (FPI), HOMA-index (HOMA-IR and HOMA-β), high sensitivity C-reactive protein (hs-CRP), total cholesterol, LDL-cholesterol, HDL-cholesterol, tryglicerides, lipoprotein (a) \\[Lp(a)\\], metalloproteinase-2 (MMP-2), metalloproteinase-9 (MMP-9), soluble adhesion molecules (sICAM-1, sVCAM-1), sE-selectin, adiponectin (ADN), complete urinalysis, 24-hour microalbuminuria.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* type 2 diabetic patients\n* naive to therapy\n* glycated hemoglobin \\> 6.5 and \\< 9.0 %\n\nExclusion Criteria:\n\n* hepatic and renal diseases\n* recent cardiovascular diseases\n* previous pancreatitis\n* history of cancer'}, 'identificationModule': {'nctId': 'NCT01895569', 'briefTitle': 'Triple Therapy in Type 2 Diabetic Patients', 'organization': {'class': 'OTHER', 'fullName': 'University of Pavia'}, 'officialTitle': 'Effects on Glycemic Variability and Glyco-metabolic Control of Metformin, Pioglitazone and Sitagliptin in Type 2 Diabetic Patients', 'orgStudyIdInfo': {'id': '20120021548'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Type 2 diabetic patients', 'description': 'Type 2 diabetic patients, naive to treatment, and not well controlled by diet (glycate hemoglobin \\> 6.5%, and \\< 9.0%) will be instructed to take metformin, followed by metformin plus pioglitazone, and then metformin plus pioglitazone plus sitagliptin.', 'interventionNames': ['Drug: Metformin', 'Drug: Pioglitazone', 'Drug: Sitagliptin']}], 'interventions': [{'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['500 mg three times a day'], 'description': 'Metformin will be added to therapy for the first threre months.', 'armGroupLabels': ['Type 2 diabetic patients']}, {'name': 'Pioglitazone', 'type': 'DRUG', 'otherNames': ['15 mg twice a day'], 'description': 'In patients not well controlled (glycated hemoglobin \\>6.5%) after three months of metformin, pioglitazone will be added.', 'armGroupLabels': ['Type 2 diabetic patients']}, {'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['100 mg once a day'], 'description': 'In patients not well controlled (glycated hemoglobin \\>6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.', 'armGroupLabels': ['Type 2 diabetic patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27100', 'city': 'Pavia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it'}, {'name': 'Pamela Maffioli, MD', 'role': 'CONTACT', 'email': 'pamelamaffioli@hotmail.it'}, {'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Pamela Maffioli, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'IRCCS Policlinico S. Matteo Foundation', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}], 'centralContacts': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'CONTACT', 'email': 'giuseppe.derosa@unipv.it'}, {'name': 'Pamela Maffioli, MD', 'role': 'CONTACT', 'email': 'pamelamaffioli@hotmail.it'}], 'overallOfficials': [{'name': 'Giuseppe Derosa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Policlinico San Matteo Foundation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pavia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fondazione IRCCS Policlinico San Matteo di Pavia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Giuseppe Derosa', 'investigatorAffiliation': 'University of Pavia'}}}}