Clinical trial NCT02989649: Non-Interventional Study of the Use of Alogliptin and Alogliptin Fixed-Dose Combinations With Pioglitazone and With Metformin in Standard Clinical Practice
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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Type 2
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2016-12-12
Enrollment: 593
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level at Month 6 in Subgroups of Participants With Different Clinical Characteristics
timeFrame: Baseline and Month 6
measure: Percentage of Participants With a Decrease in HbA1c Level by <7.0%
timeFrame: Baseline and Month 6
measure: Percentage of Participants With a Decrease in HbA1c Level by >0.3% and No Tolerability Findings
timeFrame: Baseline and Month 6
measure: Change From Baseline in Fasting Plasma Glucose (FPG) Level Over Time
timeFrame: Baseline and Months 3 and 6
measure: Change From Baseline in Glycosylated Hemoglobin (HbA1c) Level Over Time
timeFrame: Baseline and Months 3 and 6
measure: Number of Participants With Adverse Drug Reactions (ADRs), Serious Adverse Events (SAEs) and Adverse Events of Special Interest (AESIs)
timeFrame: Baseline up to Month 6
measure: Percentage of Participants Who Remain on Treatment With Alogliptin or Alogliptin FDCs
timeFrame: Months 3 and 6
measure: Time to Alogliptin or Alogliptin FDCs Dose Escalation or Dose Reduction
timeFrame: Months 3 and 6
Other outcomes:
Locations:
city: Beijing
country: China
state: Beijing
city: Wuhan
country: China
state: Hubei
city: Dalian
country: China
state: Liaoning
city: Shenyang
country: China
state: Liaoning
city: Jinan
country: China
state: Shandong
city: Qingdao
country: China
state: Shandong
city: Tai'an
country: China
state: Shandong
city: Taian
country: China
state: Shandong
city: Tianjin
country: China
state: Tianjin
city: Sai Ying Pun
country: Hong Kong
city: Sha Tin
country: Hong Kong
Study officials:
affiliation: Takeda
name: Medical Director Clinical Science
role: STUDY_DIRECTOR
References: