Efficacy and Safety of Alogliptin and Metformin Fixed-dose Combination in Patients With Type 2 Diabetes
Overview[ - collapse ][ - ]
| Purpose | The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM). |
|---|---|
| Condition | Diabetes Mellitus |
| Intervention | Drug: Alogliptin Drug: Metformin HCl Drug: Alogliptin and Metformin fixed-dose combination (FDC) Drug: Alogliptin placebo Drug: Metformin placebo Drug: Alogliptin and metformin FDC placebo |
| Phase | Phase 3 |
| Sponsor | Takeda |
| Responsible Party | Takeda |
| ClinicalTrials.gov Identifier | NCT01890122 |
| First Received | June 26, 2013 |
| Last Updated | March 24, 2014 |
| Last verified | March 2014 |
Tracking Information[ + expand ][ + ]
| First Received Date | June 26, 2013 |
|---|---|
| Last Updated Date | March 24, 2014 |
| Start Date | September 2013 |
| Estimated Primary Completion Date | March 2015 |
| Current Primary Outcome Measures | Change From Baseline to Week 26 (or Early Termination) in Glycosylated Hemoglobin (HbA1c) [Time Frame: Baseline and Week 26] [Designated as safety issue: No]The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 26 or early termination. |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| Brief Title | Efficacy and Safety of Alogliptin and Metformin Fixed-dose Combination in Patients With Type 2 Diabetes |
|---|---|
| Official Title | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of Alogliptin and Metformin Fixed Dose Combination, Alogliptin Alone, or Metformin Alone in Subjects With Type 2 Diabetes Mellitus |
| Brief Summary | The purpose of this study is to evaluate the efficacy and safety of alogliptin and metformin fixed-dose combination (FDC) as compared with alogliptin alone or metformin alone on Type 2 Diabetes Mellitus (T2DM). |
| Detailed Description | The drug being tested in this study is a fixed-dose combination tablet of alogliptin and metformin to treat people who have diabetes. This study will look at glycemic control in people who take alogliptin and metformin FDC compared with alogliptin or metformin alone. The study will enroll approximately 640 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need): - Alogliptin 12.5 mg twice daily (BID) - Metformin HCL 500 mg BID - Alogliptin 12.5 mg and Metformin HCL 500 mg FDC BID - Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient. All participants will be asked to take 2 tablets and 1 capsule twice a day at the same time each day throughout the study. All participants will be asked to record any hypoglycemic events in a diary. This multi-centre trial will be conducted in China, South Korea, and Malaysia. The overall time to participate in this study is 34 weeks. Participants will make 11 visits to the clinic. |
| Study Type | Interventional |
| Study Phase | Phase 3 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus |
| Intervention | Drug: Alogliptin Alogliptin tablets. Other Names: SYR-322; NesinaDrug: Metformin HCl Metformin capsules. Other Names: Fortamet, Glucophage, Glucophage XR, Glumetza, RiometDrug: Alogliptin and Metformin fixed-dose combination (FDC) Aloglptin and metformin FDC tablets. Other Names: KazanoDrug: Alogliptin placebo Alogliptin placebo-matching tablets. Drug: Metformin placebo Metformin placebo-matching capsules. Drug: Alogliptin and metformin FDC placebo Alogliptin and metformin FDC placebo-matching tablets. |
| Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Recruiting |
|---|---|
| Estimated Enrollment | 640 |
| Estimated Completion Date | March 2015 |
| Estimated Primary Completion Date | March 2015 |
| Eligibility Criteria | Inclusion Criteria: 1. Capable of understanding and complying with protocol requirements. 2. The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. 3. Has a historical diagnosis of T2DM. 4. Male or female and aged 18 to 75 years, inclusive. 5. Body mass index (BMI) between 20 and 45 kg/m^2, inclusive. 6. A female of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent throughout the duration of the study. 7. Is experiencing inadequate glycemic control defined as HbA1c concentration between 7.5% and 10%, inclusive, and has been treated with diet and exercise for at least 2 months prior to Screening. (Exception: a participant who has received any other diabetic therapy for less than 7 days in total within the 2 months prior to the screening, can be included). 8. If male, has a hemoglobin >12 g/dL (>120 g/L) at Screening or if female, has a hemoglobin >10 g/dL (>100 g/L) at Screening. 9. If male, has a serum creatinine <1.5 mg/dL at Screening or if female, has a serum creatinine <1.4 mg/dL at Screening, and estimated glomerular filtration rate (eGFR) >60 mL/min/1.73 m^2 based on calculation using the Modification of Diet in Renal Disease (MDRD) at Screening. 10. Willing and able to monitor their own blood glucose concentrations using a home glucose monitor and complete a subject diary. Exclusion Criteria: 1. Participated in another clinical study within 90 days prior to Screening. 2. Received any investigational compound within 30 days prior to Randomization. 3. Received a dipeptidyl peptidase-4 (DPP-4) inhibitor within 3 months prior to screening. 4. History of laser treatment for proliferative diabetic retinopathy within the 6 months prior to Screening. 5. History of treatment for diabetic gastric paresis, gastric banding, or gastric bypass surgery. 6. History of diabetic ketoacidosis or hyperosmolar non-ketotic coma. 7. Chronic pancreatitis and/or history of acute pancreatitis. 8. Systolic blood pressure >180 mmHg and/or diastolic blood pressure >110 mmHg at Screening. 9. History of any hemoglobinopathy or diagnosis of chronic anemia. 10. New York Heart Association Class III or IV heart failure. (Participants who are stable at Class I or II and are currently treated, are candidates for the study.) 11. History of coronary angioplasty, coronary stent placement, coronary bypass surgery, or myocardial infarction within 6 months prior to Screening. 12. History of any cancer, other than squamous cell or basal cell carcinoma of the skin, which has not been in full remission for at least 5 years prior to Screening. Participants with a history of treated cervical intraepithelial neoplasia [CIN] I or CIN II are allowed. 13. Significant clinical sign or symptom of hepatopathy, acute or chronic hepatitis, human immunodeficiency virus or alanine aminotransferase (ALT) is 2.5 times above upper limit of normal value. 14. History of angioedema in association with use of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin II receptor blockers (ARB). 15. History of hypersensitivity or allergies to any DPP-4 inhibitor and/or metformin or related compounds. 16. Has used oral or systemically injected glucocorticoids (including intra-articular injection) or has used weight-loss drugs within 2 months prior to Screening. (Inhaled or topical corticosteroids were allowed.) 17. History of alcohol or substance abuse within 2 years prior to Screening. 18. Has used medicine for weight loss within 60 days prior to Screening (such as Xenical, Sibutramine, Phenylpropanolamine or similar nonprescription drugs). 19. History of organ transplantation. 20. Is an immediate family member, study site employee, or is in a dependant relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress. 21. Has, in the judgment of the investigator, any major illness or debility that may prohibit the participant from completing the study. 22. If female, is pregnant or lactating or intending to become pregnant before, during, or within 1 month after participating in this study; or intending to donate ova during such time period. |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Contact: Takeda Study Registration Call Center 800-778-2860 medicalinformation@tpna.com |
| Location Countries | China, Korea, Republic of, Malaysia |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01890122 |
|---|---|
| Other Study ID Numbers | SYR-322MET_303 |
| Has Data Monitoring Committee | No |
| Information Provided By | Takeda |
| Study Sponsor | Takeda |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Director Takeda |
| Verification Date | March 2014 |
Locations[ + expand ][ + ]
| China, Beijing | Beijing, Beijing, China Recruiting |
|---|---|
| China, Guangdong | Guangzhou, Guangdong, China Recruiting |
| China, Guangxi | Nanning, Guangxi, China Recruiting |
| China, Hebei | Hengshui, Hebei, China Recruiting |
| China, Hebei | Shijiazhuang, Hebei, China Recruiting |
| China, Hubei | Shiyan, Hubei, China Recruiting |
| China, Hubei | Wuhan, Hubei, China Recruiting |
| China, Hunan | Changsha, Hunan, China Recruiting |
| China, Hunan | Yueyang, Hunan, China Recruiting |
| China, Jiangsu | Changzhou, Jiangsu, China Recruiting |
| China, Jiangsu | Nanjing, Jiangsu, China Recruiting |
| China, Jiangsu | Suzhou, Jiangsu, China Recruiting |
| China, Jiangxi | Nanchang, Jiangxi, China Recruiting |
| China, Jilin | Changchun, Jilin, China Recruiting |
| China, Liaoning | Shenyang, Liaoning, China Recruiting |
| China, Shanxi | Xi'an, Shanxi, China Recruiting |
| China, Sichuan | Chengdu, Sichuan, China Recruiting |
| China, Zhejiang | Wenzhou, Zhejiang, China Recruiting |
| China | Beijing, China Recruiting |
| China | Shanghai, China Recruiting |
| China | Shanghai, China Not yet recruiting |
| China | Tianjin, China Recruiting |
| Korea, Republic of, Gyeonggi-do | Goyang-si, Gyeonggi-do, Korea, Republic of Recruiting |
| Korea, Republic of, Gyeonggi-do | Suwon, Gyeonggi-do, Korea, Republic of Recruiting |
| Korea, Republic of | Busan, Korea, Republic of Recruiting |
| Korea, Republic of | Daejeon, Korea, Republic of Recruiting |
| Korea, Republic of | Jeonju-si, Jeollabuk-do, Korea, Republic of Recruiting |
| Korea, Republic of | Seoul, Korea, Republic of Recruiting |
| Malaysia, Johor | Johor Bahru, Johor, Malaysia Recruiting |
| Malaysia, Kedah Darul Aman | Alor Setar, Kedah Darul Aman, Malaysia Recruiting |
| Malaysia, Kelantan | Kubang Kerian, Kelantan, Malaysia Recruiting |
| Malaysia, Perak | Ipoh, Perak, Malaysia Recruiting |