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