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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02989649
• Other study ID #: Alogliptin-5009
• Status: Terminated
• Start date: December 22, 2016
• Est. completion date: January 26, 2018

Study information

• Verified date: January 2019
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 593
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• Alogliptin
Alogliptin tablets
• Alogliptin FDC With Pioglitazone
Alogliptin FDC with pioglitazone tablets
• Alogliptin FDC With Metformin
Alogliptin FDC with metformin tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Countries where clinical trial is conducted

China,  Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Baseline and Month 6
Secondary	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.	Baseline and Month 6
Secondary	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.	Baseline and Month 6
Secondary	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%.	Baseline and Month 6
Secondary	Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time	The change between the fasting plasma glucose value collected at Months 3 and 6 relative to baseline. A negative change from Baseline indicates improvement.	Baseline and Months 3 and 6
Secondary	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.	Baseline and Months 3 and 6
Secondary	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.	Baseline up to Month 6
Secondary	Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs		Months 3 and 6
Secondary	Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction		Months 3 and 6