Ignite Creation Date:
2025-12-25 @ 1:28 AM
Ignite Modification Date:
2025-12-27 @ 11:07 PM
Study NCT ID:
NCT01026194
Status:
COMPLETED
Last Update Posted:
2014-01-16
First Post:
2009-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
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The adverse events which occured from Week 0 to Week 12 were shown.', 'otherNumAtRisk': 101, 'otherNumAffected': 47, 'seriousNumAtRisk': 101, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Teneli/Teneli + Pio (Data Through Week 12)', 'description': 'Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 0 to Week 12 were shown.', 'otherNumAtRisk': 103, 'otherNumAffected': 63, 'seriousNumAtRisk': 103, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Placebo/Teneli + Pio (Data From Week 12 to Week 52)', 'description': 'Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. The adverse events which occured from Week 12 to Week 52 were shown.', 'otherNumAtRisk': 98, 'otherNumAffected': 89, 'seriousNumAtRisk': 98, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Teneli/Teneli + Pio (Data Through Week 52)', 'description': 'Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone. 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98, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 4}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 33}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 33}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Gastritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Herpes dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Folliculitis', 'stats': 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0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Laryngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Oesophageal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 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'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Tinea pedis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Urethritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Infections and infestations'}, {'term': 'Gingival abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Infections and 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'Hyperphosphatasaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Gout', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders'}, {'term': 'Hyperuricaemia', 'stats': 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1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 2}], 'organSystem': 'Nervous system disorders'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Tension headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 103, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Lacunar infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 101, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 103, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, 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Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline AUC0-2h for Postprandial Plasma Glucose as a covariate.'}, {'measure': 'Change From Baseline in 2-hour Postprandial Plasma Glucose at Week 12', 'timeFrame': 'at Week 0 and Week 12', 'description': 'The change from Baseline in 2-hour Postprandial Plasma Glucose collected at Week 12. Least squares means were derived from an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline 2-hour Postprandial Plasma Glucose as a covariate.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['insulin resistance'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24843712', 'type': 'DERIVED', 'citation': 'Kadowaki T, Kondo K. Efficacy and safety of teneligliptin in combination with pioglitazone in Japanese patients with type 2 diabetes mellitus. J Diabetes Investig. 2013 Nov 27;4(6):576-84. doi: 10.1111/jdi.12092. Epub 2013 May 27.'}, {'pmid': '24205974', 'type': 'DERIVED', 'citation': 'Kadowaki T, Kondo K. Efficacy and safety of teneligliptin added to glimepiride in Japanese patients with type 2 diabetes mellitus: a randomized, double-blind, placebo-controlled study with an open-label, long-term extension. Diabetes Obes Metab. 2014 May;16(5):418-25. doi: 10.1111/dom.12235. Epub 2013 Dec 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy and safety of MP-513 (Teneligliptin) in combination with thiazolidinedione (pioglitazone) in patients with type 2 Diabetes for 12 weeks administration and to evaluate the safety and efficacy of MP-513 in combination with thiazolidinedione with an extension treatment for up to 52 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who are 20 - 75 years old\n* Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug\n* Patients whose HbA1c is between 6.5% and 10.0%\n* Patients who took Thiazolidinedione for diabetes over 16 weeks before administration of investigational drug\n* Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug.\n\nExclusion Criteria:\n\n* Patients with type 1 diabetes, diabetes mellitus caused by pancreas impairment, or secondary diabetes (Cushing disease, acromegaly, etc)\n* Patients who are accepting treatments of arrhythmias\n* Patients with serious diabetic complications\n* Patients who are the excessive alcohol addicts\n* Patients with severe hepatic disorder or severe renal disorder.\n* Patients who are pregnant, lactating, and probably pregnant patients, and patients who can not agree to contraception'}, 'identificationModule': {'nctId': 'NCT01026194', 'briefTitle': 'Efficacy and Safety Study of MP-513 in Combination With Thiazolidinedione in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Tanabe Pharma Corporation'}, 'officialTitle': 'A Phase III Study of MP-513 in Combination With Thiazolidinedione in Japanese Patients With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '3000-A7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo / Teneli + Pio', 'interventionNames': ['Drug: Placebo / Teneli (Teneligliptin) + pio (pioglitazone)']}, {'type': 'EXPERIMENTAL', 'label': 'Teneli / Teneli + pio', 'interventionNames': ['Drug: Teneli / Teneli + pio']}], 'interventions': [{'name': 'Placebo / Teneli (Teneligliptin) + pio (pioglitazone)', 'type': 'DRUG', 'description': 'Placebo for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.', 'armGroupLabels': ['Placebo / Teneli + Pio']}, {'name': 'Teneli / Teneli + pio', 'type': 'DRUG', 'description': 'Teneligliptin for 12 weeks (double-blind period) followed by teneligliptin for an additional 40 weeks (open-label period) in combination with pioglitazone.', 'armGroupLabels': ['Teneli / Teneli + pio']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shinjukuku', 'state': 'Tokyo', 'country': 'Japan'}], 'overallOfficials': [{'name': 'Takashi Kadowaki, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tokyo University'}, {'name': 'Kazuoki Kondo, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Tanabe Pharma Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tanabe Pharma Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}