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

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

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.

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

Details

• Lead Sponsor: Kyunghee University Medical Center
• Collaborators: Ajou University School of Medicine; Bucheon St. Mary's Hospital; Inha University Hospital; Kangbuk Samsung Hospital; Korea University Guro Hospital; Kyung Hee University Hospital at Gangdong; Seoul Medical Center; Takeda
• Treatments: Alogliptin; Glimepiride; Pioglitazone

Criteria

Inclusion Criteria:

• Type 2 Diabetes Mellitus patients

• Patient who had been diagnosed within the previous 12 months with HbA1c levels of 8.0-12.0%, did not have a medical history related to diabetes, and did not display proliferative retinopathy

Exclusion Criteria:

• The use of weight-lowering drugs, any investigational blood-glucose or lipid-lowering agent (other than statins or ezetimibe) within the past 3 months

• Previous treatment with systemic corticosteroids or a change in dosage of thyroid hormones in the previous 6 weeks

• The use of insulin within the 3 months prior to screening

• Others