The purpose of this study is to evaluate the effect of alogliptin benzoate (VIPIDIA®) on glycosylated hemoglobin (HbA1c) level dynamics in participants with diabetes mellitus type 2 (T2DM) at Month 6.
The drug being studied in this study is called alogliptin benzoate. Alogliptin benzoate is being researched to treat people who have T2DM. This study will look at the HbA1c level dynamics in participants with T2DM. The study enrolled 1409 patients. Alogliptin benzoate will be prescribed by their physician in accordance with the Russian summary of product characteristics (SmPC). This multi-center study will be conducted in the Russian Federation. The overall duration of study for observation will be approximately 6 months. Participants will make multiple visits to the clinic as assigned by each physician according to their routine practice, in every 3 months.
Study Type
OBSERVATIONAL
Enrollment
1,409
Alogliptin benzoate tablets
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 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 and T2DM duration. 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% 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. Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported.
Time frame: Baseline and Month 6
Change From Baseline in 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. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement.
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First City Clinical Hospital named after E.E. Vlosevich
Arkhangelsk, Russia
City polyclinic #11
Barnaul, Russia
Belgorod Regional Clinical hospital named after Saint I Belgorod Regional Clinical Hospital of St. Joasaph
Belgorod, Russia
LLC Medical center Lotos
Chelyabinsk, Russia
Istochnik clinic
Chelyabinsk, Russia
Regional clinical hospital #3
Chelyabinsk, Russia
Medical center Health Academy
Chita, Russia
Chita State Medical Academy
Chita, Russia
City polyclinic #11
Kazan', Russia
Ciry polyclinic #10
Kazan', Russia
...and 43 more locations
Time frame: Baseline, Months 3 and 6
Percentage of Participants With Marked Hyperglycemia at Month 3
Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L.
Time frame: Month 3
Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time
The change in the value of fasting plasma glucose value collected at Months 3 and 6 relative to baseline. Target FPG depended on the defined individual targets of glycemic control by HbA1c level ≤6.5 to 8.0 mmol/l. A negative change from Baseline indicates improvement.
Time frame: Baseline, Months 3 and 6
Change From Baseline in Weight Over Time
Change in the participant's weight was collected at Months 3 and 6 relative to baseline.
Time frame: Baseline, Months 3 and 6
Change From Baseline in Postprandial Glycemia Over Time
The change between the baseline (pre-prandial (before meal)) and postprandial (after meal) glucose values were collected at Months 3 and 6 relative to baseline.
Time frame: Baseline, Months 3 and 6
Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time
The change between the total cholesterol triglycerides, low density lipoproteins and high density lipoproteins values were collected at Months 3 and 6 relative to baseline.
Time frame: Baseline, Months 3 and 6
Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% 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. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported.
Time frame: Baseline and Month 6
Percentage of Participants Who Used Healthcare Resources
Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage.
Time frame: Baseline up to Month 6