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Sponsored by: |
Takeda Global Research & Development Center, Inc. |
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Information provided by: | Takeda Global Research & Development Center, Inc. |
ClinicalTrials.gov Identifier: | NCT00856284 |
The purpose of this study is to determine the safety and effectiveness of adding alogliptin compared to glipizide with metformin in diabetic subjects.
Condition | Intervention | Phase |
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Type 2 Diabetes Mellitus |
Drug: Alogliptin and metformin Drug: Glipizide and metformin |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Double-Blind, Active-Controlled Study to Evaluate the Durability of the Efficacy and Safety of Alogliptin Compared to Glipizide When Used in Combination With Metformin in Subjects With Type 2 Diabetes |
Estimated Enrollment: | 2445 |
Study Start Date: | April 2009 |
Estimated Study Completion Date: | April 2013 |
Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Drug: Alogliptin and metformin
Alogliptin 12.5 mg, tablets, orally, once daily, Glipizide placebo-matching tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
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2: Experimental |
Drug: Alogliptin and metformin
Alogliptin 25 mg, tablets, orally, once daily, Glipizide placebo-matching tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
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3: Active Comparator |
Drug: Glipizide and metformin
Glipizide 5 mg, tablets, orally, once daily, Alogliptin placebo-matching tablets, orally, once daily and the maximum tolerated dose of metformin (1500 mg to 3300 mg daily) for up to 104 weeks.
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For patients diagnosed with type 2 diabetes mellitus, metformin is the usual first-line therapy in addition to diet control and exercise. For those patients with inadequate glycemic control with metformin monotherapy or experiencing serious side effects of metformin, sulfonylurea is a popular choice as a second-line oral antidiabetic treatment.
Alogliptin is a dipeptidyl peptidase-4 inhibitor currently being developed by Takeda for use in patients with type 2 diabetes mellitus.
This study is designed to further explore the durability of efficacy and safety of alogliptin compared to glipizide in type 2 diabetes mellitus subjects whose blood sugar level is inadequately controlled with metformin therapy.
The duration of this study will be approximately 2 years.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Study Director: | Vice President Biological Sciences | Takeda Global Research & Development Center, Inc. |
Responsible Party: | Takeda Global Research & Development Center, Inc. ( Sr. VP, Clinical Science ) |
Study ID Numbers: | SYR-322_305, 2008-007444-34, U1111-1111-7397 |
Study First Received: | March 4, 2009 |
Last Updated: | September 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00856284 History of Changes |
Health Authority: | United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Austria: Ethikkommission; Brazil: National Committee of Ethics in Research; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Dominican Republic: Secretaría del Estado de Salud Pública y Asistencia Social (SESPAS); Hong Kong: Department of Health; Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee; Hungary: National Institute of Pharmacy; Israel: Ethics Commission; Italy: Ministry of Health; Malaysia: Ministry of Health; Mexico: Ethics Committee; Mexico: Federal Commission for Protection Against Health Risks; Mexico: Federal Commission for Sanitary Risks Protection; New Zealand: Health and Disability Ethics Committees; Peru: General Directorate of Pharmaceuticals, Devices, and Drugs; Peru: Ministry of Health; Philippines: Department of Health; Philippines: Bureau of Food and Drugs; Poland: Ministry of Health; Romania: Ethics Committee; Russia: Ministry of Health and Social Development of the Russian Federation; South Africa: Department of Health; South Korea: Institutional Review Board; South Korea: Korea Food and Drug Administration (KFDA); Spain: Ethics Committee; Spain: Ethics Committee; Thailand: Ethical Committee; Thailand: Ministry of Public Health; Ukraine: Ministry of Health; United Kingdom: Research Ethics Committee |
Diabetes Mellitus Drug Therapy Hyperinsulinism Hyperglycemia Glucose Intolerance |
Metabolic Diseases Glipizide Glucose Intolerance Metformin Diabetes Mellitus Endocrine System Diseases Hyperinsulinism |
Hyperglycemia Hypoglycemic Agents Diabetes Mellitus, Type 2 Endocrinopathy Glucose Metabolism Disorders Metabolic Disorder |
Hypoglycemic Agents Glipizide Metabolic Diseases Physiological Effects of Drugs Metformin |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |