Safety and Efficacy of Alogliptin in Indian Participants With Type 2 Diabetes Mellitus

• Status: Withdrawn
• Trial end date: 2018-01-15
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety and efficacy of alogliptin tablets when given as monotherapy or add on therapy in participants who are on standard care for management of Type 2 Diabetes Mellitus (T2DM).

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

Details

• Lead Sponsor: Takeda
• Treatments: Alogliptin

Criteria

Inclusion Criteria:

1. Participants with T2DM who are dipeptidyl peptidase-4 (DPP-4) inhibitor-naive; including alogliptin.

Exclusion Criteria:

1. Has contraindication or limitation for administration of alogliptin tablets according to the approved label/Prescribing Information.

2. Participants treated with alogliptin tablets outside the approved label/ prescribing information.

3. Has end-stage renal disease (ESRD) (Creatinine Clearance (CrCl) <15 mL/min or requiring hemodialysis).