Diabetes Mellitus
Conditions
Keywords
Drug Therapy
Brief summary
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.
Detailed description
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.
Interventions
Alogliptin benzoate tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male and female participants ≥ 18 years of age; 2. Has a diagnosis of type 2 diabetes mellitus (T2DM) 3. Participants with: * newly diagnosed diabetes mellitus (DM) type 2 (drug naïve) or * inadequate glycemic control on previously prescribed any oral antidiabetic drug. 4. VIPIDIA® is prescribed according to the approved label for the Russian Federation. 5. The participant's physician decides to prescribe VIPIDIA®: * as monotherapy or * as a part of combination therapy. 6. The participant (or, when applicable, the participant's legally acceptable representative) signs and dates a written, informed consent form prior to the start of data collection. Participant is capable of understanding the written informed consent, provides signed and written informed consent, and agrees to comply with protocol requirements. In case the participant is blind or unable to read, informed consent will also be witnessed.
Exclusion criteria
1. Contraindications of respective approved Russian summary of product characteristics (SmPC); 2. In the opinion of the physician, the participant has any reasons of medical and non-medical character, which in the opinion of the physician can prevent participant participation in the study; 3. Had 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 VIPIDIA® treatment. 4. Is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (eg, spouse, parent, child, sibling) or may consent under duress.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With a Decrease in HbA1c Level by <7.0% 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. Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported. |
| Change From Baseline in HbA1c Level Over Time | Baseline, 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. Glycosylated hemoglobin (HbA1c) as a diagnostic criteria of diabetes mellitus is ≥6.5%. A negative change from Baseline indicates improvement. |
| Percentage of Participants With Marked Hyperglycemia at Month 3 | Month 3 | Marked hyperglycemia is defined as fasting plasma glucose (FPG) higher than or equal to 11 mmol/L. |
| Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | Baseline, Months 3 and 6 | 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. |
| Change From Baseline in 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 and T2DM duration. A negative change from Baseline indicates improvement. |
| Change From Baseline in Postprandial Glycemia Over Time | Baseline, Months 3 and 6 | 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. |
| Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Baseline, Months 3 and 6 | 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. |
| Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% 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. Percentage of participants with a decrease of ≥0.3% from baseline in HbA1c were reported. |
| Percentage of Participants Who Used Healthcare Resources | Baseline up to Month 6 | Healthcare resources included rate of hospitalization, emergency, emergency room visits, physician office visits, and other type of usage. |
| Change From Baseline in Weight Over Time | Baseline, Months 3 and 6 | Change in the participant's weight was collected at Months 3 and 6 relative to baseline. |
Countries
Russia
Participant flow
Recruitment details
Participants took part in the study in Russia from 20-Sep-2016 to 28-Apr-2018.
Pre-assignment details
Participants with a diagnosis of diabetes mellitus type 2 (T2DM) prescribed alogliptin benzoate in accordance with Russian SmPC were enrolled in this observational study.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin Benzoate Participants with diabetes mellitus type 2 (T2DM) who received alogliptin benzoate tablets, orally, as prescribed by physician according to Russian summary of product characteristics (SmPC) were observed for approximately 6 months. | 1,399 |
| Total | 1,399 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Insufficient Efficacy | 2 |
| Overall Study | Lost for Observation | 13 |
| Overall Study | Lost for Observation after Baseline | 6 |
| Overall Study | Patient's Unwillingness | 12 |
| Overall Study | Protocol Deviation | 10 |
| Overall Study | Reason not Specified | 9 |
| Overall Study | Sponsor Decision/Regulatory Requirement | 1 |
Baseline characteristics
| Characteristic | Alogliptin Benzoate |
|---|---|
| Age, Continuous | 58.1 years STANDARD_DEVIATION 9.9 |
| Race/Ethnicity, Customized African American or African | 3 Participants |
| Race/Ethnicity, Customized Asian | 21 Participants |
| Race/Ethnicity, Customized European | 1375 Participants |
| Region of Enrollment Russia | 1399 Participants |
| Sex: Female, Male Female | 907 Participants |
| Sex: Female, Male Male | 492 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 1,399 |
| other Total, other adverse events | 69 / 1,399 |
| serious Total, serious adverse events | 5 / 1,399 |
Outcome results
Primary
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
Population: All participants with a diagnosis of diabetes mellitus type 2 (T2DM), newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 | Baseline | 8.1 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 | Change from Baseline at Month 6 | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | Baseline | 8.7 mmol/l | Standard Deviation 2.1 |
| Alogliptin Benzoate | Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | Change from Baseline to Month 3 | -1.7 mmol/l | Standard Deviation 1.8 |
| Alogliptin Benzoate | Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | Change from Month 3 to Month 6 | -0.4 mmol/l | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in Fasting Plasma Glucose (FPG) Levels Over Time | Change from Baseline to Month 6 | -2.1 mmol/l | Standard Deviation 2 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy Diabetes Mellitus (DM), No Therapy | -1.4 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Monotherapy: Biguanides | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 0.8 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Monotherapy: Sulfonylureas | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1.3 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Monotherapy: Other | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 0 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Biguanides+Sulfonylureas | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Biguanides+SGLT2 inhibitors | -1.4 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Prior Therapy DM, Combined therapy: Other | -1.8 percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Sex, Male | -1.4 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Sex,Female | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Age Group, <58 Years | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Age Group, ≥58 Years | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Cardiovascular (CV) Risk Group, High CV Risk | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | CV Risk Group, Very High CV Risk | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Therapy Type (TT), Monotherapy: VIPIDIA® | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+Biguanides | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+Sulfonylureas | -1 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+SGLT2 Inhibitors | 0 percentage of glycosylated hemoglobin | Standard Deviation 0 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+Biguanides+Sulfonylureas | -1.4 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+Biguanides+SGLT2 Inhibitors | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT, Combined: VIPIDIA®+Biguanides+Antidiabetics | -2.4 percentage of glycosylated hemoglobin | Standard Deviation 0 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | TT,Combined: VIPIDIA®+Biguanide+Sulfonylurea+SGLT2 | -2.1 percentage of glycosylated hemoglobin | Standard Deviation 0.5 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | BMI, Normal Weight (<25 kg/m^2) | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | BMI, Over-Weight (25≤BMI<30 kg/m^2) | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | BMI, Obesity Class I (30≤BMI<35 kg/m^2) | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | BMI, Obesity Class II (35≤BMI<40 kg/m^2) | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | BMI, Obesity Class III (BMI≥40 kg/m^2) | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Glycemic Control, HBA1C<7.5% | -0.6 percentage of glycosylated hemoglobin | Standard Deviation 0.5 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Glycemic Control, 7.5%≥HBA1C<9% | -1.1 percentage of glycosylated hemoglobin | Standard Deviation 0.6 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | Glycemic Control, HBA1C≥9% | -2.5 percentage of glycosylated hemoglobin | Standard Deviation 1.4 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | T2DM Duration, 0-3 Years | -1.3 percentage of glycosylated hemoglobin | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | T2DM Duration, 3-5 Years | -1.0 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | T2DM Duration, 5-10 Years | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics | T2DM Duration, >=10 Years | -1.2 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
Secondary
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.
Time frame: Baseline, Months 3 and 6
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in HbA1c Level Over Time | Baseline | 8.1 percentage of glycosylated hemoglobin | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level Over Time | Change from Baseline to Month 3 | -0.8 percentage of glycosylated hemoglobin | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in HbA1c Level Over Time | Change from Month 3 to Month 6 | -0.4 percentage of glycosylated hemoglobin | Standard Deviation 0.5 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in Postprandial Glycemia Over Time | Baseline | 10.4 mmol/l | Standard Deviation 2.2 |
| Alogliptin Benzoate | Change From Baseline in Postprandial Glycemia Over Time | Change from Baseline to Month 3 | -1.9 mmol/l | Standard Deviation 2 |
| Alogliptin Benzoate | Change From Baseline in Postprandial Glycemia Over Time | Change from Month 3 to Month 6 | -0.5 mmol/l | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in Postprandial Glycemia Over Time | Change from Baseline to Month 6 | -2.4 mmol/l | Standard Deviation 2.2 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Total Cholesterol, Baseline | 5.6 mmol/l | Standard Deviation 1.2 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Total Cholesterol, Change from Baseline to Month 3 | -0.5 mmol/l | Standard Deviation 0.8 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Total Cholesterol, Change from Month 3 to Month 6 | -0.2 mmol/l | Standard Deviation 0.6 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Total Cholesterol, Change from Baseline to Month 6 | -0.6 mmol/l | Standard Deviation 1 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Triglycerides, Baseline | 2.2 mmol/l | Standard Deviation 2.2 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Triglycerides, Change from Baseline to Month 3 | -0.4 mmol/l | Standard Deviation 1.7 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Triglycerides, Change from Month 3 to Month 6 | -0.1 mmol/l | Standard Deviation 0.5 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Triglycerides, Change from Baseline to Month 6 | -0.4 mmol/l | Standard Deviation 1.6 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | Low Density Lipoproteins (LDL), Baseline | 3.4 mmol/l | Standard Deviation 1.1 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | LDL, Change from Baseline to Month 3 | -0.4 mmol/l | Standard Deviation 0.7 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | LDL, Change from Month 3 to Month 6 | -0.2 mmol/l | Standard Deviation 0.6 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | LDL, Change from Baseline to Month 6 | -0.6 mmol/l | Standard Deviation 0.9 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | High Density Lipoproteins (HDL), Baseline | 1.3 mmol/l | Standard Deviation 0.5 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | HDL, Change from Baseline to Month 3 | 0.0 mmol/l | Standard Deviation 0.3 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | HDL, Change from Month 3 to Month 6 | 0.0 mmol/l | Standard Deviation 0.3 |
| Alogliptin Benzoate | Change From Baseline in Total Cholesterol, Triglycerides, Low Density Lipoproteins and High Density Lipoproteins Over Time | HDL, Change from Baseline to Month 6 | 0.1 mmol/l | Standard Deviation 0.4 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study. Number analyzed is the number of participants with evaluable data at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin Benzoate | Change From Baseline in Weight Over Time | Baseline | 90.6 kg | Standard Deviation 16.5 |
| Alogliptin Benzoate | Change From Baseline in Weight Over Time | Change from Baseline to Month 3 | -1.5 kg | Standard Deviation 3 |
| Alogliptin Benzoate | Change From Baseline in Weight Over Time | Change from Month 3 to Month 6 | -1.1 kg | Standard Deviation 2.9 |
| Alogliptin Benzoate | Change From Baseline in Weight Over Time | Change from Baseline to Month 6 | -2.6 kg | Standard Deviation 4.2 |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Alogliptin Benzoate | Percentage of Participants Who Used Healthcare Resources | Rate of Hospitalization | 0.6 percentage of participants |
| Alogliptin Benzoate | Percentage of Participants Who Used Healthcare Resources | Rate of Emergency | 0.1 percentage of participants |
| Alogliptin Benzoate | Percentage of Participants Who Used Healthcare Resources | Rate of Physician Office Visits | 0.6 percentage of participants |
| Alogliptin Benzoate | Percentage of Participants Who Used Healthcare Resources | Rate of Other Type of Usage | 0.1 percentage of participants |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alogliptin Benzoate | Percentage of Participants With a Decrease in HbA1c Level by ≥0.3% at Month 6 | 89.1 percentage of participants |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alogliptin Benzoate | Percentage of Participants With a Decrease in HbA1c Level by <7.0% at Month 6 | 52 percentage of participants |
Secondary
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
Population: All participants with a diagnosis of T2DM, newly diagnosed T2DM (drug naive) or inadequate glycemic control on previously prescribed any oral antidiabetic drug were enrolled in the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alogliptin Benzoate | Percentage of Participants With Marked Hyperglycemia at Month 3 | 0.9 percentage of participants |