Overview

The Practical Evidence of Antidiabetic Combination Therapy in Korea

Status:
Completed
Trial end date:
2019-01-28
Target enrollment:
0
Participant gender:
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 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Kun-Ho Yoon
Collaborator:
Takeda
Treatments:
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