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

NCT ID: NCT03042325

Last Updated: 2017-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-30

Study Completion Date

2018-01-15

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Diabetes Mellitus, Type 2

Keywords

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Drug therapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Alogliptin

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 \[CrCl\].

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Interventions

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Alogliptin

Alogliptin tablets

Intervention Type DRUG

Other Intervention Names

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SYR-322 Nesina

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director Clinical Science

Role: STUDY_DIRECTOR

Takeda

Other Identifiers

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U1111-1174-1852

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322-4001

Identifier Type: -

Identifier Source: org_study_id