Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan
Overview[ - collapse ][ - ]
Purpose | To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID). |
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Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin and glimepiride Drug: Alogliptin and glimepiride Drug: Alogliptin and metformin Drug: Alogliptin and metformin |
Phase | Phase 2/Phase 3 |
Sponsor | Takeda |
Responsible Party | Takeda |
ClinicalTrials.gov Identifier | NCT01318135 |
First Received | March 16, 2011 |
Last Updated | July 7, 2012 |
Last verified | July 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | March 16, 2011 |
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Last Updated Date | July 7, 2012 |
Start Date | January 2009 |
Estimated Primary Completion Date | April 2010 |
Current Primary Outcome Measures | Number of Participants With Adverse Events. [Time Frame: 52 Weeks.] [Designated as safety issue: Yes]Treatment-emergent adverse events (TEAE) are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug through 30 days after receiving the last dose of study drug. A TEAE may also be a pretreatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug that increases in severity after the start of dosing. |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Long-term Safety Study of Alogliptin Used in Combination With Sulfonylurea or Metformin in Participants With Type 2 Diabetes in Japan |
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Official Title | A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan |
Brief Summary | To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID). |
Detailed Description | Both insulin hyposecretion and insulin-resistance are considered to be involved in the development of type 2 diabetes mellitus. Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes. This was a phase 2/3, multicenter, open-label study, in participants who had completed the core phase 2/3 sulfonylurea add-on study (SYR-322/CCT-005; NCT01318083) or the core phase 2/3 metformin add-on study (SYR-322/CCT-006; NCT01318109) to evaluate the safety and efficacy of alogliptin administered as an add-on to a sulfonylurea (glimepiride) or metformin continuously for 40 weeks (52 weeks from the start of study treatment with alogliptin in the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study). |
Study Type | Interventional |
Study Phase | Phase 2/Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment |
Condition | Type 2 Diabetes Mellitus |
Intervention | Drug: Alogliptin and glimepiride Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. Other Names:
Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks. Other Names:
Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. Other Names:
Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks. Other Names:
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Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 576 |
Estimated Completion Date | April 2010 |
Estimated Primary Completion Date | January 2010 |
Eligibility Criteria | Inclusion Criteria: Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study: 1. Had completed the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study. 2. Was capable of understanding and complying with protocol requirements. 3. Signed a written informed consent form prior to the initiation of any study procedure. Exclusion Criteria: Common criteria that applied to participants completing both the core phase 2/3 sulfonylurea add-on study and those completing the core phase 2/3 metformin add-on study: 1. With clinical manifestation of hepatic impairment (eg, an aspartate aminotransferase or alanine aminotransferase value of 2.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study). 2. With clinical manifestation of renal impairment (eg, a creatinine value of 1.5 times or more of the upper reference limit at Week 8 of the core phase 2/3 sulfonylurea add-on study or the core phase 2/3 metformin add-on study). 3. With serious cardiac disease, cerebrovascular disorder, or serious pancreatic or hematological disease (eg, a subject who requires hospital admission). Criteria that applied only to participants completing the core phase 2/3 metformin add-on study: 1. With history or symptoms of lactic acidosis. |
Gender | Both |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | Not Provided |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01318135 |
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Other Study ID Numbers | SYR-322/OCT-005 |
Has Data Monitoring Committee | No |
Information Provided By | Takeda |
Study Sponsor | Takeda |
Collaborators | Not Provided |
Investigators | Study Director: Professor, Diabetes and Endocrine Division Department of Medicine, Kawasaki Medical School |
Verification Date | July 2012 |