Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

593 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-22

Study Completion Date

2018-01-26

Brief Summary

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The purpose of this study is to observe alogliptin and alogliptin fixed-dose combinations (FDCs) utilization patterns, as well as clinical response to treatment with alogliptin or alogliptin FDCs, in standard clinical practice.

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Detailed Description

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The drug being studied in this study is called alogliptin and alogliptin FDCs. Alogliptin and alogliptin FDCs is being researched to treat people who have diabetes mellitus type 2. This study will look at the glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2.

The study enrolled 593 patients. Alogliptin and alogliptin FDCs will be prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study).

This multi-center study will be conducted in China. The overall duration of study for observation will be approximately 6 months, or up to loss to follow-up or death, whichever occurs first. Participants will make multiple visits to the clinic as per regular doctor's appointments.

Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)

Participants with type 2 diabetes mellitus (T2DM) who received alogliptin or alogliptin FDCs, orally, prescribed by the physician as part of participants' T2DM treatment program (independent of participation in this study) were observed for approximately 6 months, or up to loss to follow-up or death, whichever occurred first.

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Alogliptin FDC With Pioglitazone

Intervention Type DRUG

Alogliptin FDC with pioglitazone tablets

Alogliptin FDC With Metformin

Intervention Type DRUG

Alogliptin FDC with metformin tablets

Interventions

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Alogliptin

Alogliptin tablets

Intervention Type DRUG

Alogliptin FDC With Pioglitazone

Alogliptin FDC with pioglitazone tablets

Intervention Type DRUG

Alogliptin FDC With Metformin

Alogliptin FDC with metformin tablets

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Has a diagnosis of T2DM.
2. Has made the decision, along with his/her treating physician, to begin treatment with alogliptin or alogliptin fixed-dose combinations (FDCs).
3. Has an glycated hemoglobin (HbA1c) value recorded at most 3 months before initiation of treatment with alogliptin or alogliptin FDCs.
4. Alogliptin or alogliptin FDCs is prescribed according to the approved label for China and Hong Kong.

Exclusion Criteria

1. Has gestational diabetes or type 1 diabetes mellitus.
2. Has used Dipeptidyl peptidase-4 inhibitors (DPP-IV inhibitors) or Glucagon like peptide-1 agonists (aGLP-1) within the 3 months prior to the start of alogliptin or alogliptin FDCs treatment.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No