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

• Sponsor: Takeda (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT02989649
• Collaborator: (none)
• Enrollment: 593
• Locations: 11
• Actual Duration (Months): 13.1
• Patients Per Site: 53.9
• Patients Per Site Per Month: 4.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: Alogliptin; Drug: Alogliptin FDC With Pioglitazone; Drug: Alogliptin FDC With Metformin

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 593 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
• Actual Study Start Date: Dec 22, 2016
• Actual Primary Completion Date: Jan 26, 2018
• Actual Study Completion Date: Jan 26, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Alogliptin; Alogliptin tablets; Drug: Alogliptin FDC With Pioglitazone; Alogliptin FDC with pioglitazone tablets; Drug: Alogliptin FDC With Metformin; Alogliptin FDC with metformin tablets

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

3. 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%.

4. 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.

5. 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.

6. 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.

7. Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs [Months 3 and 6]

8. Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction [Months 3 and 6]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Beijing	Beijing	China
2		Wuhan	Hubei	China
3		Dalian	Liaoning	China
4		Shenyang	Liaoning	China
5		Jinan	Shandong	China
6		Qingdao	Shandong	China
7		Tai'an	Shandong	China
8		Taian	Shandong	China
9		Tianjin	Tianjin	China
10		Sai Ying Pun		Hong Kong
11		Sha Tin		Hong Kong

Sponsors and Collaborators

• Takeda

Investigators

• Study Director: Medical Director Clinical Science, Takeda

Study Documents (Full-Text)

• Study Protocol - Apr 1, 2016
• Statistical Analysis Plan - Mar 12, 2018

More Information

Publications

None provided.

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT02989649
• Other Study ID Numbers: Alogliptin-5009
• First Posted: Dec 12, 2016
• Last Update Posted: Apr 19, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Takeda: Drug Therapy
• Additional relevant MeSH terms: Diabetes Mellitus, Type 2; Metformin; Pioglitazone; Alogliptin

Study Results

Participant Flow

Recruitment Details	Participants took part in the study at 16 investigative sites in China from 22 Dec 2016 to 26 Jan 2018.
Pre-assignment Detail	Participants with a diagnosis of Type 2 Diabetes Mellitus (T2DM) prescribed alogliptin or alogliptin Fixed Dose Combinations (FDCs) with either metformin or pioglitazone were enrolled in this observational study.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Period Title: Overall Study
STARTED	593
Started But Not Treated	84
Eligible to Enter Into Treatment Period	509
COMPLETED	173
NOT COMPLETED	420

Baseline Characteristics

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Overall Participants	509
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	55.3 (12.65)
Age, Customized (Count of Participants)
<45 years	92 18.1%
>=45 to <65 years	309 60.7%
>=65 years	108 21.2%
Sex: Female, Male (Count of Participants)
Female	207 40.7%
Male	302 59.3%
Race/Ethnicity, Customized (Count of Participants)
Asian	508 99.8%
White	1 0.2%
Race/Ethnicity, Customized (Count of Participants)
Han Nationality	504 99%
Other	5 1%
Region of Enrollment (Count of Participants)
China	509 100%
Height (cm) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cm]	167.37 (8.089)
Weight (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	72.66 (12.208)
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	25.86 (3.500)
Body Mass Index, Customized (Count of Participants)
<25 kg/m^2	193 37.9%
25 to <30 kg/m^2	256 50.3%
>=30 kg/m^2	51 10%
Missing	9 1.8%
Glycosylated hemoglobin (HbA1c) Level (percentage of glycosylated hemoglobin) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	8.690 (1.8807)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	140
Mean (Standard Deviation) [percentage of glycosylated hemoglobin]	-1.092 (1.6803)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for data at Baseline compared to the data at Month 6
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean (LSM)
	Estimated Value	-1.25
	Confidence Interval	(2-Sided) 95%; -1.44 to -1.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.098
	Estimation Comments	The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.

2. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	140
Prior Therapy of Diabetes Mellitus, Ever Used	-1.154 (1.7555)
Prior Therapy of Diabetes Mellitus, Never Used	-0.882 (1.4015)
Sex, Male	-1.055 (1.5898)
Sex, Female	-1.150 (1.8292)
Age, <45 years	-1.658 (1.8206)
Age, >=45 to <65 years	-1.370 (1.7121)
Age,>=65 years	-0.203 (1.1423)
Cardiovascular Risk Group, Yes	-1.100 (2.4973)
Cardiovascular Risk Group, No	-1.092 (1.6400)
Therapy Type, Monotherapy	-1.032 (1.5122)
Therapy Type, Combined Therapy	-1.106 (1.7222)
Baseline BMI, <25 kg/m^2	-1.101 (1.7339)
Baseline BMI, 25 to <30 kg/m^2	-1.037 (1.6151)
Baseline BMI, >=30 kg/m^2	-1.342 (1.8530)
Initial Glycemic Control, <7%	-0.046 (0.7345)
Initial Glycemic Control, >=7%	-1.525 (1.7713)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Prior therapy of diabetes mellitus, Ever used or Never used
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.423
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Sex, Male or Female
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.747
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Age, <45 or >=45 to <65 years or >=65 years
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Cardiovascular risk group, Yes or No
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.990
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Therapy type, Monotherapy or Combined therapy
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.841
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Baseline BMI, <25 or 25 to <30 or >=30 kg/m^2
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.847
	Comments
	Method	Regression, Linear
	Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for subgroup: Initial glycemic control, <7% or >=7%
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Linear
	Comments

3. Secondary Outcome

Title	Percentage of Participants With a Decrease in HbA1c Level by <7.0%
Description	Percentage of participants with a decrease of <7.0% from baseline in HbA1c were reported.
Time Frame	Baseline and Month 6

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	147
Number [percentage of participants]	51.0 10%

4. Secondary Outcome

Title	Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Overall number of participants analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	140
Number [percentage of participants]	64.3 12.6%

5. Secondary Outcome

Title	Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	509
Month 3	-1.058 (3.0026)
Month 6	-0.714 (2.9802)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for data at Baseline compared to the data at Month 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean (LSM)
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.62
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.170
	Estimation Comments	The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for data at Baseline compared to the data at Month 6
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean (LSM)
	Estimated Value	-0.87
	Confidence Interval	(2-Sided) 95%; -1.36 to -0.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.245
	Estimation Comments	The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.

6. Secondary Outcome

Title	Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	509
Month 3	-1.022 (2.3669)
Month 6	-1.092 (1.6803)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for data at Baseline compared to the data at Month 3
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean (LSM)
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 95%; -1.18 to -0.72
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.117
	Estimation Comments	The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Comments	Statistical analysis for data at Baseline compared to the data at Month 6
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Least Square Mean
	Estimated Value	-1.25
	Confidence Interval	(2-Sided) 95%; -1.44 to -1.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.098
	Estimation Comments	The LSM and CI are from Mixed effect Model Repeat Measurement (MMRM) model, that used visit as a predictor and baseline value as a covariate. For change from baseline, covariance structure=Unstructured.

7. Secondary Outcome

Title	Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
Description	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

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	509
Adverse Drug Reaction (ADR)	1 0.2%
Serious Adverse Event (SAE)	0 0%
Adverse Event of Special Interest (AESI)	0 0%

8. Secondary Outcome

Title	Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
Time Frame	Months 3 and 6

Outcome Measure Data

Analysis Population Description

All participants dosed included participants with complete demographic information and eligible for the study and dosed at least once. Number analyzed is the number of participants with evaluable data at the given time-point.

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	509
Month 3	100 19.6%
Month 6	100 19.6%

9. Secondary Outcome

Title	Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
Time Frame	Months 3 and 6

Outcome Measure Data

Analysis Population Description

No participant was experienced the dose adjustment (dose escalation or dose reduction).

Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
Measure Participants	0

Adverse Events

Time Frame	Up to Month 6
Adverse Event Reporting Description	At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment.
Arm/Group Title	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
Arm/Group Description	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.
All Cause Mortality
	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Affected / at Risk (%)	# Events
Total	0/509 (0%)
Serious Adverse Events
	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Affected / at Risk (%)	# Events
Total	0/509 (0%)
Other (Not Including Serious) Adverse Events
	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)
	Affected / at Risk (%)	# Events
Total	55/509 (10.8%)
Gastrointestinal disorders
Abdominal discomfort	48/509 (9.4%)
Hepatobiliary disorders
Hepatic function abnormal	2/509 (0.4%)
Infections and infestations
Gastroenteritis	1/509 (0.2%)
Metabolism and nutrition disorders
Hypertriglyceridaemia	2/509 (0.4%)
Dyslipidaemia	1/509 (0.2%)
Hyperuricaemia	1/509 (0.2%)
Vascular disorders
Hypertension	2/509 (0.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi-site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.