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.
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.
Study Type
OBSERVATIONAL
Enrollment
593
Alogliptin tablets
Alogliptin FDC with pioglitazone tablets
Alogliptin FDC with metformin tablets
Unnamed facility
Beijing, Beijing Municipality, China
Unnamed facility
Wuhan, Hubei, China
Unnamed facility
Dalian, Liaoning, China
Unnamed facility
Shenyang, Liaoning, China
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at 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.
Time frame: Baseline and Month 6
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
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.
Time frame: Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported.
Time frame: Baseline and Month 6
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
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%.
Time frame: Baseline and Month 6
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
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Unnamed facility
Jinan, Shandong, China
Unnamed facility
Qingdao, Shandong, China
Unnamed facility
Taian, Shandong, China
Unnamed facility
Tai’an, Shandong, China
Unnamed facility
Tianjin, Tianjin Municipality, China
Unnamed facility
Sai Ying Pun, Hong Kong
...and 1 more locations
The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.
Time frame: Baseline and Months 3 and 6
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
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 frame: Baseline and Months 3 and 6
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
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.
Time frame: Baseline up to Month 6
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
Time frame: Months 3 and 6
Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Time frame: Months 3 and 6