Overview
The Practical Evidence of Antidiabetic Combination Therapy in Korea
Status:
Completed
Completed
Trial end date:
2019-01-28
2019-01-28
Target enrollment:
0
0
Participant gender:
All
All
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 diabetic patients in Korea.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Kun-Ho YoonCollaborator:
TakedaTreatments:
Alogliptin
Metformin
Pioglitazone
Criteria
Inclusion Criteria:- 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
- 7.0% =
- 18.5 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 Criteria:
- 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