Efficacy of Pioglitazone in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg as compared with pioglitazone 15 mg on glycemic control as when used in patients with inadequately controlled type 2 diabetes mellitus treated with fixed combinations of metformin and sulfonylurea. |
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Condition | Type II Diabetes Mellitus |
Intervention | Drug: Pioglitazone Drug: Metformin Drug: Sulfonylurea |
Phase | Phase 4 |
Sponsor | Takeda |
Responsible Party | Takeda |
ClinicalTrials.gov Identifier | NCT01972724 |
First Received | October 24, 2013 |
Last Updated | October 24, 2013 |
Last verified | October 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | October 24, 2013 |
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Last Updated Date | October 24, 2013 |
Start Date | November 2013 |
Estimated Primary Completion Date | November 2014 |
Current Primary Outcome Measures | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]The change from Baseline in glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) at Week 24. |
Current Secondary Outcome Measures | Change From Baseline in Fasting Plasma Glucose at Week 24 [Time Frame: Baseline and Week 24] [Designated as safety issue: No]The change between the value of fasting serum glucose collected at Week 24 and fasting serum glucose collected at Baseline. |
Descriptive Information[ + expand ][ + ]
Brief Title | Efficacy of Pioglitazone in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy |
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Official Title | A 24-Week, Randomized, Double-Blind, Phase IV Trial to Evaluate the Efficacy of Pioglitazone 30 mg in Patients With Inadequately Controlled Type 2 Diabetes Mellitus Treated With Stable Triple Oral Therapy of Metformin, Sulfonylurea, and Pioglitazone 15 Mg (ADD Trial) |
Brief Summary | The purpose of this study is to evaluate the efficacy of pioglitazone 30 mg as compared with pioglitazone 15 mg on glycemic control as when used in patients with inadequately controlled type 2 diabetes mellitus treated with fixed combinations of metformin and sulfonylurea. |
Detailed Description | The drug being tested in this study is called pioglitazone. Pioglitazone is being tested to treat glycemic control in adults with inadequately controlled type 2 diabetes mellitus. This study will look at glycemic control in people who take triple oral therapy of metformin, sulfonylurea, and pioglitazone 15 mg. The study will enroll approximately 310 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): - Pioglitazone 15 mg + Metformin and sulfonylurea - Pioglitazone 30 mg + Metformin and sulfonylurea All participants will be asked to take one pioglitazone tablet at the same time each day throughout the study as well as continuing their previous dose of metformin and sulfonylurea.. This multi-centre trial will be conducted in Korea. The overall time to participate in this study is up to 25 weeks. Participants will make 4 visits to the hospital or endocrinologist's office, and will be contacted by telephone 7 days after last dose of study drug for a follow-up assessment. |
Study Type | Interventional |
Study Phase | Phase 4 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type II Diabetes Mellitus |
Intervention | Drug: Pioglitazone Pioglitazone tablets Other Names: ACTOSDrug: Metformin Metformin tablets Drug: Sulfonylurea Sulfonylurea tablets |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Not yet recruiting |
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Estimated Enrollment | 310 |
Estimated Completion Date | November 2014 |
Estimated Primary Completion Date | November 2014 |
Eligibility Criteria | Inclusion Criteria: 1. Institutional Review Board (IRB)-approved written informed consent form (ICF) must be obtained from the patient or legally authorized representative prior to any trial related procedure (including withdrawal of prohibited medication, if applicable) 2. Patients with a history of clinical diagnosis of established type 2 diabetes mellitus defined by the ADA criteria 2012 3. Male or female between 18 and 80 years of age 4. Patients with stable triple oral therapy of metformin + sulfonylurea + pioglitazone (ACTOS) 15 mg or ACTOSMET(Pioglitazone 15mg/Metformin 850mg) and sulfonylurea for at least 12 weeks at the screening visit 5. Patients with HbA1c ≥7.0% at the screening visit 6. Patients with C-peptide ≥1.0 ng/mL at the screening visit 7. Females of childbearing potential who are sexually active must agree to use adequate contraception, and can neither be pregnant nor lactating from screening throughout the duration of the study, up to 60 days after the last dose of the study medication Exclusion Criteria: 1. Patients with type 1 diabetes mellitus or secondary forms of diabetes 2. Patients who have been treated with insulin for ≥7 days within 3 months prior to the screening visit 3. Patients with a history of bladder cancer or patients with active bladder cancer 4. Patients with a history of acute diabetic complications such as diabetic ketoacidosis 5. Patients with a history of acute or chronic metabolic acidosis, including diabetic ketoacidosis 6. Patients with unstable or rapidly progressive diabetic retinopathy, nephropathy (estimated glomerular filtration rate [eGFR] <60mL/min/1.73m2) 7. Patients with cardiac insufficiency (e.g., a myocardial infarction, a coronary angioplasty or bypass graft, unstable angina, transient ischemic attacks, or a documented cerebrovascular accident within 6 months prior to the screening visit) 8. Patients with cardiac failure or history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4) 9. Patients with a serum alanine transaminase (ALT) level ≥2.5 times the upper limit of normal (ULN), active liver disease, or jaundice 10. Patients taking concomitant gemfibrozil or other strong cytochrome P450 (CYP)2C8 inhibitors 11. Patients with a history of recurrent or severe hypoglycemia 12. Patients with a history of any hemoglobinopathy (such as hemolytic anemias or sickle cell disease) that may affect determination of HbA1c 13. Patients with uninvestigated microscopic hematuria 14. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption, since the study drug contains lactose 15. Patients with any other condition judged by the Investigator as unsuitable for the study 16. Patients who have used any investigational or experimental drugs or devices within 60 days of the screening visit 17. Lactating or pregnant female. A positive pregnancy test before the first administration of investigational medicinal product or breastfeeding 18. Male patients planning to father during clinical trial conduct or within 3 months after the last planned dose of the IMP 19. Patients were previously enrolled into the current clinical trial 20. Prior to the start of the clinical trial the patient participated in the active treatment phase of another clinical trial where a persisting pharmacodynamic effect of the IMP of that clinical trial cannot be excluded (e.g., patient is well into a treatment-free follow-up phase) 21. Patients are considered unable or unwilling to co-operate adequately, i.e., to follow clinical trial procedures and Investigator instructions adequately (e.g., language difficulties, etc.) or patients are anticipated not to be available for scheduled clinical trial visits/procedures. |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com |
Location Countries | Korea, Republic of |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01972724 |
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Other Study ID Numbers | PG-9999-301-KR |
Has Data Monitoring Committee | No |
Information Provided By | Takeda |
Study Sponsor | Takeda |
Collaborators | Not Provided |
Investigators | Study Director: Medical Director Takeda |
Verification Date | October 2013 |
Locations[ + expand ][ + ]
Korea, Republic of | Chagwon, Korea, Republic of Not yet recruiting |
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Korea, Republic of | Daegu, Korea, Republic of Not yet recruiting |
Korea, Republic of | Daejeon, Korea, Republic of Not yet recruiting |
Korea, Republic of | Gwangju, Korea, Republic of Not yet recruiting |
Korea, Republic of | Jeonju, Korea, Republic of Not yet recruiting |
Korea, Republic of | Seoul, Korea, Republic of Not yet recruiting |
Korea, Republic of | Seoungnam, Korea, Republic of Not yet recruiting |
Korea, Republic of | Ulsan, Korea, Republic of Not yet recruiting |
Korea, Republic of | Wonju, Korea, Republic of Not yet recruiting |