Status:
COMPLETED
The Practical Evidence of Antidiabetic Combination Therapy in Korea
Lead Sponsor:
Kun-Ho Yoon
Collaborating Sponsors:
Takeda
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
19-75 years
Phase:
PHASE4
Brief Summary
This study evaluate the efficacy and safety of alogliptin and pioglitazone combination therapy in comparison with either alogliptin or pioglitazone on glucose control in the metformin-treated type 2 d...
Detailed Description
Pathophysiology of type 2 diabetes is known as insulin resistance and progressive beta cell dysfunction. Combination therapy with biguanides, glucagon-like peptide-1(GLP-1) agonists or dipeptidyl pep...
Eligibility Criteria
Inclusion
- In the opinion of the investigator, the subject is capable of understanding and complying with protocol requirements
- The subject or, when applicable, the subject'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
- The subjects diagnosed type 2 diabetes mellitus at least 6 months
- Male and female and 19 to 75 years, inclusive
- 0% =\<HbA1c =\<10.0%
- 5 Kg/m2 =\<Body Mass Index(BMI) =\<45 kg/m2
- systolic/diastolic blood pressure =\<160/100 at baseline
- hemoglobin of at least 12 g/dL for men and at least 10 g/dL for women
- A female subject of childbearing potential who is sexually active with a nonsterilized male partner agrees to routinely use adequate contraception from singing of informed consent throughout the duration of the study
- Patient who receiving maximal tolerated dose of metformin at least 12 weeks without dose change (for metformin, \>= 1,000 mg/day
- fasting c-peptide greater than 0.78 ng/mL(0.26 nmol/L) at baseline
Exclusion
- The patient has received investigational compound(alogliptin or pioglitazone) within 180 days prior to baseline
- Patient who currently taking or need to take andy medicine which may exert a significant influence on blood glucose control except metformin.
- Severe renal disease : estimated glomerular filtration rate \<50 mL/min
- Severe liver disease or AST, ALT \>= 2.5 upper limit of normal
- Cardiac status : New York Heart Association III \~ IV
- Hypopituitarism or adrenal insufficiency
- Patient who has a history of major surgery, Severe infections, Severe traumas within 6 months
- Patients who has diagnosed malignancy within 5yrs ,
- Patients with active bladder cancer
- Patient with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patient who has a history of hypersensitivity to Alogliptin, Pioglitazone or their ingredients
- Pregnant or lactating woman
- Patient who has history of excessive alcohol abuse
- Subject who is involved in other clinical trial within 90 days prior to initiation of this study.
- Subject who the investigator deems inappropriate to participate in this study
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 28 2019
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT02231021
Start Date
September 1 2014
End Date
January 28 2019
Last Update
February 8 2019
Active Locations (1)
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1
Seoul St Mary's Hospital, The Catholic University of Korea
Seoul, South Korea, 137-701