An Extension Study of PEAK Trial

• Status: Terminated
• Trial end date: 2019-02-28
• Target enrollment: 0
• Participant gender: All

Summary

Double blind, three arm, comparative intervention trial for 24 weeks(PEAK study) with open label extension trial for 28 weeks followed by 2 year observational study.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kun-Ho Yoon
• Collaborator: Takeda
• Treatments: Alogliptin; Metformin; Pioglitazone

Criteria

Inclusion Criteria:

• Completed "ALO-IIT-012(PEAK study)", without major protocol deviations.

• Male, or female, 19 years to 75 years.

• Female with childbearing potential who has a negative urine pregnancy test result at study start and willing to continue practice appropriate birth control during the entire duration of study

• Subjects completed PEAK can be included within 30 days after End Of the Study

• Subjects completed PEAK can be included if their treatment is the same as randomized even after 30 days of End Of the Study.

Exclusion Criteria:

• eGFR(Epidermal growth factor receptor) < 50mL/min

• AST(aspartate aminotransferase)/ALT(alanine aminotransaminase) >2.5 upper limit of normal

• Pregnant or lactating women

• Subject who the investigator deems inappropriate to participate in this study

• Patients with a history of bladder cancer or patients with active bladder cancer

• Patients with uninvestigated macroscopic hematuria

• Patients with cardiac failure or a history of cardiac failure (New York Heart Association [NYHA] Stages 3 to 4)

• Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption, since this study drug contains lactose