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

Takeda

Status and phase: Withdrawn; Phase 4

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Alogliptin

Study type: Interventional

Funder types: Industry

Identifiers

NCT03042325

U1111-1174-1852 (Registry Identifier)

SYR-322-4001

Details and patient eligibility

About

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).

Full description

The drug being tested in this study is called alogliptin. Alogliptin is being tested to treat people who have Type 2 Diabetes Mellitus (T2DM). This study will look at side effects and glycemic control in people who take alogliptin in addition to standard care.

The study will enroll approximately 300 patients. All participants will receive alogliptin tablets at a dose determined based on the creatinine clearance.

The recommended dose of alogliptin is 25 mg once daily with normal or mildly impaired renal function (creatinine clearance [CrCl] ≥60 mL/min), dose of 12.5 mg for participants with moderate renal impairment (CrCl ≥30 to <60 mL/min), and 6.25 mg for participants severe renal impairment (CrCl ≥15 to <30 mL/min). Participants with end-stage renal disease (ESRD) (CrCl <15 mL/min or requiring hemodialysis) will be excluded, in addition to standard care for the management of T2DM.

All participants will be asked to take one tablet every morning each day throughout the study.

This multi-center trial will be conducted in India. The overall time to participate in this study is up to 33 weeks. Participants will make multiple visits to the clinic, and will be contacted by telephone 30 days after last dose of study drug for a follow-up assessment.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Alogliptin

Experimental group

Description:

Alogliptin 25 mg, tablets, orally, once, daily for 26 weeks in addition to standard care for the management of Type 2 Diabetes Mellitus (T2DM). Dose will be adjusted as per creatinine clearance \[CrCl\].

Treatment:

Drug: Alogliptin