NCT02823808

Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function

Effect of Alogliptin/Pioglitazone on the Preservation of Long-term Beta-cell Function After Early Intensive Diabetes Treatment

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 96 (estimated)
• Sponsor: Kyunghee University Medical Center · Academic / Other
• Sex: All
• Age: 26 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

All subjects will be randomized as Alo/Pio combo group (intervention) or Glim/Met combo group (control) after intensive COAD treatment based on identical protocol. * All subject will be managed with once daily, fixed dose, single tablet treatment based on the study protocol, and followed-up for 104 weeks. * Any group of subjects who fail to reach glycemic target with single tablet treatment, subject will be treated with rescue medication and stopped regular observation.

Conditions

• Diabetes

Interventions

Type	Name	Description
DRUG	NESINA ACT TAB. 25/15mg	Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
DRUG	AMARYL-M TAB. 2/500mg	Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.

Timeline

• Start date: 2017-07-01
• Primary completion: 2021-07-01
• Completion: 2021-12-01
• First posted: 2016-07-06
• Last updated: 2017-07-25

Locations

1 site across 1 country: South Korea