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

Terminated

Conditions: Diabetes Mellitus, Type 2

Interventions: Drug: Alogliptin
Drug: Alogliptin FDC With Pioglitazone
Drug: Alogliptin FDC With Metformin

Registration Number: NCT02989649

Lead Sponsor: Takeda

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 593

Inclusion Criteria

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

Exclusion Criteria

Has gestational diabetes or type 1 diabetes mellitus.
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.

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)	Alogliptin FDC With Pioglitazone	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 or Alogliptin Fixed Dose Combinations (FDCs)	Alogliptin FDC With Metformin	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 or Alogliptin Fixed Dose Combinations (FDCs)	Alogliptin	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.

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6	Baseline and Month 6	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With a Decrease in HbA1c Level by <7.0%	Baseline and Month 6	Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics	Baseline and Month 6	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Month 6 relative to baseline. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. Subgroups included participants with different baseline clinical characteristics with predictors such as prior therapy of diabetes mellitus, sex, age group, cardiovascular risk group, therapy type (monotherapy or combined therapy), baseline body mass index (BMI) and initial glycemic control. A negative change from Baseline indicates improvement.
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings	Baseline and Month 6	Percentage of participants with a decrease of \>0.3% from baseline in HbA1c along with no tolerability findings were reported. Tolerability findings included hypoglycemic event, or weight gain ≥5%.
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time	Baseline and Months 3 and 6	The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)	Baseline up to Month 6	An ADR is defined as any response to a medicinal product that is noxious and unintended and that occurs at doses normally used in humans for the prophylaxis, diagnosis, or therapy of diseases or for the restoration, correction, or modification of physiological function. An SAE is defined as any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or is medically important due to other reasons than the above mentioned criteria. Adverse events such as pancreatitis, hepatic disorders, and hypersensitivity reactions (including angioedema, anaphylaxis, and Stevens-Johnson syndrome) were considered as AESI.
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs	Months 3 and 6
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time	Baseline and Months 3 and 6	The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction	Months 3 and 6