Trial Outcomes & Findings for Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice (NCT NCT02989649)

NCT ID: NCT02989649

Last Updated: 2019-04-19

Results Overview

Recruitment status

TERMINATED

Target enrollment

593 participants

Primary outcome timeframe

Baseline and Month 6

Results posted on

2019-04-19

Participant Flow

Participants took part in the study at 16 investigative sites in China from 22 Dec 2016 to 26 Jan 2018.

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	593
Overall Study Started But Not Treated	84
Overall Study Eligible to Enter Into Treatment Period	509
Overall Study COMPLETED	173
Overall Study NOT COMPLETED	420

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Patient/Investigator's Decision to Stop	403
Overall Study Adverse Event/Adverse Drug Reaction	1
Overall Study Lost For Observation During Study	3
Overall Study Reason Not Specified	13

Baseline Characteristics

Number analyzed is the number of participants with evaluable data for this baseline measure.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 Participants 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.
Age, Continuous	55.3 years STANDARD_DEVIATION 12.65 • n=509 Participants
Age, Customized <45 years	92 Participants n=509 Participants
Age, Customized >=45 to <65 years	309 Participants n=509 Participants
Age, Customized >=65 years	108 Participants n=509 Participants
Sex: Female, Male Female	207 Participants n=509 Participants
Sex: Female, Male Male	302 Participants n=509 Participants
Race/Ethnicity, Customized Asian	508 Participants n=509 Participants
Race/Ethnicity, Customized White	1 Participants n=509 Participants
Race/Ethnicity, Customized Han Nationality	504 Participants n=509 Participants
Race/Ethnicity, Customized Other	5 Participants n=509 Participants
Region of Enrollment China	509 Participants n=509 Participants
Height	167.37 cm STANDARD_DEVIATION 8.089 • n=500 Participants • Number analyzed is the number of participants with evaluable data for this baseline measure.
Weight	72.66 kg STANDARD_DEVIATION 12.208 • n=500 Participants • Number analyzed is the number of participants with evaluable data for this baseline measure.
Body Mass Index (BMI)	25.86 kg/m^2 STANDARD_DEVIATION 3.500 • n=500 Participants • Number analyzed is the number of participants with evaluable data for this baseline measure.
Body Mass Index, Customized <25 kg/m^2	193 Participants n=509 Participants
Body Mass Index, Customized 25 to <30 kg/m^2	256 Participants n=509 Participants
Body Mass Index, Customized >=30 kg/m^2	51 Participants n=509 Participants
Body Mass Index, Customized Missing	9 Participants n=509 Participants
Glycosylated hemoglobin (HbA1c) Level	8.690 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.8807 • n=498 Participants • Number analyzed is the number of participants with evaluable data for this baseline measure.

PRIMARY outcome

Timeframe: Baseline and Month 6

Population: 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.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=140 Participants 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6	-1.092 percentage of glycosylated hemoglobin Standard Deviation 1.6803

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=140 Participants 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy of Diabetes Mellitus, Ever Used	-1.154 percentage of glycosylated hemoglobin Standard Deviation 1.7555
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Prior Therapy of Diabetes Mellitus, Never Used	-0.882 percentage of glycosylated hemoglobin Standard Deviation 1.4015
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Sex, Male	-1.055 percentage of glycosylated hemoglobin Standard Deviation 1.5898
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Age, <45 years	-1.658 percentage of glycosylated hemoglobin Standard Deviation 1.8206
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Age, >=45 to <65 years	-1.370 percentage of glycosylated hemoglobin Standard Deviation 1.7121
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Age,>=65 years	-0.203 percentage of glycosylated hemoglobin Standard Deviation 1.1423
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Cardiovascular Risk Group, Yes	-1.100 percentage of glycosylated hemoglobin Standard Deviation 2.4973
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Cardiovascular Risk Group, No	-1.092 percentage of glycosylated hemoglobin Standard Deviation 1.6400
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Therapy Type, Monotherapy	-1.032 percentage of glycosylated hemoglobin Standard Deviation 1.5122
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Therapy Type, Combined Therapy	-1.106 percentage of glycosylated hemoglobin Standard Deviation 1.7222
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Baseline BMI, <25 kg/m^2	-1.101 percentage of glycosylated hemoglobin Standard Deviation 1.7339
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Baseline BMI, 25 to <30 kg/m^2	-1.037 percentage of glycosylated hemoglobin Standard Deviation 1.6151
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Baseline BMI, >=30 kg/m^2	-1.342 percentage of glycosylated hemoglobin Standard Deviation 1.8530
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Initial Glycemic Control, <7%	-0.046 percentage of glycosylated hemoglobin Standard Deviation 0.7345
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Initial Glycemic Control, >=7%	-1.525 percentage of glycosylated hemoglobin Standard Deviation 1.7713
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics Sex, Female	-1.150 percentage of glycosylated hemoglobin Standard Deviation 1.8292

SECONDARY outcome

Timeframe: Baseline and Month 6

Percentage of participants with a decrease of \<7.0% from baseline in HbA1c were reported.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=147 Participants 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.
Percentage of Participants With a Decrease in HbA1c Level by <7.0%	51.0 percentage of participants Interval 0.43 to 0.59

SECONDARY outcome

Timeframe: 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%.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=140 Participants 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.
Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings	64.3 percentage of participants Interval 0.56 to 0.72

SECONDARY outcome

Timeframe: Baseline and Months 3 and 6

Population: 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.

The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 Participants 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.
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time Month 3	-1.058 mg/dL Standard Deviation 3.0026
Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time Month 6	-0.714 mg/dL Standard Deviation 2.9802

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 Participants 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.
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time Month 3	-1.022 percentage of glycosylated hemoglobin Standard Deviation 2.3669
Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time Month 6	-1.092 percentage of glycosylated hemoglobin Standard Deviation 1.6803

SECONDARY outcome

Timeframe: Baseline up to Month 6

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

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.

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 Participants 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.
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Adverse Event of Special Interest (AESI)	0 Participants
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Adverse Drug Reaction (ADR)	1 Participants
Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs) Serious Adverse Event (SAE)	0 Participants

SECONDARY outcome

Timeframe: Months 3 and 6

Outcome measures

Outcome measures
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 Participants 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.
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs Month 3	100 percentage of participants
Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs Month 6	100 percentage of participants

SECONDARY outcome

Timeframe: Months 3 and 6

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

Outcome measures

Outcome data not reported

Adverse Events

Alogliptin or Alogliptin Fixed Dose Combinations (FDCs)

Serious events: 0 serious events

Other events: 55 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Alogliptin or Alogliptin Fixed Dose Combinations (FDCs) n=509 participants at risk 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.
Gastrointestinal disorders Abdominal discomfort	9.4% 48/509 • Up to Month 6 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.
Metabolism and nutrition disorders Hypertriglyceridaemia	0.39% 2/509 • Up to Month 6 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.
Metabolism and nutrition disorders Dyslipidaemia	0.20% 1/509 • Up to Month 6 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.
Metabolism and nutrition disorders Hyperuricaemia	0.20% 1/509 • Up to Month 6 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.
Hepatobiliary disorders Hepatic function abnormal	0.39% 2/509 • Up to Month 6 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.
Vascular disorders Hypertension	0.39% 2/509 • Up to Month 6 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.
Infections and infestations Gastroenteritis	0.20% 1/509 • Up to Month 6 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.

Additional Information

Medical Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER