Clinical trial NCT03555591: Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
Official title: Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 3198
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with type 2 diabetes mellitus in the routine clinical setting

Brief summary: The purpose of this survey is to evaluate the long-term safety and efficacy of trelagliptin tablets in patients with type 2 diabetes mellitus in the routine clinical setting.

Detailed description: The drug being tested in this survey is called trelagliptin tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus.

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the trelagliptin tablet in the routine clinical setting. The planned number of observed patients will be approximately 3000.

This multi-center observational trial will be conducted in Japan.

Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus patients

Exclusion Criteria:

1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
2. Have severe infection, perioperative status, or serious trauma
3. Have severe renal impairment or on dialysis due to end-stage renal disease
4. Have a history of hypersensitivity to any ingredients of this drug

Primary outcomes:
measure: Number of Participants Who Had One or More Adverse Events
timeFrame: 36 months
measure: Number of Participants Who Had One or More Adverse Drug Reactions
timeFrame: 36 months
Secondary outcomes:
measure: Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Change From Baseline in Fasting Blood Glucose
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Change From Baseline in Fasting Insulin Level
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Change From Baseline in Fasting Glucagon
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
timeFrame: Baseline, up to final assessment point (up to Month 36)
measure: Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
timeFrame: Baseline, up to final assessment point (up to Month 36)
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Takeda Selected Site
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: