Trial Outcomes & Findings for Specified Drug-Use Survey of Trelagliptin Tablets "Survey on Long-term Use in Type 2 Diabetes Mellitus Patients With Severe Renal Impairment or End-stage Renal Disease" (NCT NCT04285983)
NCT ID: NCT04285983
Last Updated: 2024-08-23
Results Overview
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Recruitment status
COMPLETED
Target enrollment
89 participants
Primary outcome timeframe
Up to Month 12
Results posted on
2024-08-23
Participant Flow
Participants took part in the survey at 12 investigative sites in Japan, from 1 March 2020 to 31 January 2023.
Participants with a historical diagnosis of type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal failure were enrolled. Participants received trelagliptin as part of a routine medical care.
Participant milestones
| Measure |
Trelagliptin 25 mg
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Overall Study
STARTED
|
89
|
|
Overall Study
COMPLETED
|
83
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Trelagliptin 25 mg
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Overall Study
Protocol Violation
|
6
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Trelagliptin 25 mg
n=83 Participants
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Age, Continuous
|
77.5 Years
STANDARD_DEVIATION 9.21 • n=83 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=83 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=83 Participants
|
|
Region of Enrollment
Japan
|
83 Participants
n=83 Participants
|
|
Duration of Type 2 Diabetes Mellitus
|
17.4 Years
STANDARD_DEVIATION 10.08 • n=54 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Weight
|
58.42 Kilograms (kg)
STANDARD_DEVIATION 11.611 • n=75 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
BMI
|
23.04 Kilogram (kg)/meter (m)^2]
STANDARD_DEVIATION 3.625 • n=72 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Height
|
159.2 Centimeters (cm)
STANDARD_DEVIATION 9.88 • n=76 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Healthcare Category
Outpatient
|
83 Participants
n=83 Participants
|
|
Healthcare Category
Inpatient
|
0 Participants
n=83 Participants
|
|
Dialysis Treatment Status
Had No Dialysis Treatment
|
63 Participants
n=83 Participants
|
|
Dialysis Treatment Status
Had Dialysis Treatment
|
20 Participants
n=83 Participants
|
|
Predisposition to Hypersensitivity
Had No Predisposition to Hypersensitivity
|
63 Participants
n=83 Participants
|
|
Predisposition to Hypersensitivity
Had Predisposition to Hypersensitivity
|
18 Participants
n=83 Participants
|
|
Predisposition to Hypersensitivity
Unknown
|
2 Participants
n=83 Participants
|
|
Medical Complications
Had No Medical Complications
|
0 Participants
n=83 Participants
|
|
Medical Complications
Had Medical Complications
|
83 Participants
n=83 Participants
|
|
Medical History
Had No Medical History
|
18 Participants
n=83 Participants
|
|
Medical History
Had Medical History
|
60 Participants
n=83 Participants
|
|
Medical History
Unknown
|
5 Participants
n=83 Participants
|
|
Smoking Classification
Never Smoked
|
43 Participants
n=83 Participants
|
|
Smoking Classification
Current Smoker
|
10 Participants
n=83 Participants
|
|
Smoking Classification
Ex-Smoker
|
22 Participants
n=83 Participants
|
|
Smoking Classification
Unknown
|
8 Participants
n=83 Participants
|
|
Alcohol Classification
No
|
16 Participants
n=83 Participants
|
|
Alcohol Classification
Yes
|
60 Participants
n=83 Participants
|
|
Alcohol Classification
Unknown
|
7 Participants
n=83 Participants
|
|
Hepatic Impairment
Had No Hepatic Impairment
|
69 Participants
n=83 Participants
|
|
Hepatic Impairment
Had Hepatic Impairment
|
14 Participants
n=83 Participants
|
|
Glycated hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)]
|
6.71 Percent
STANDARD_DEVIATION 0.956 • n=67 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Fasting Blood Glucose
|
124.5 milligram (mg)/deciliter (dL)
STANDARD_DEVIATION 40.48 • n=31 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Serum Creatinine Value Within 3 Months Before Start of Treatment with the Study Drug
|
2.399 mg/dL
STANDARD_DEVIATION 1.1757 • n=57 Participants • The number analyzed is the number of participants with data available for analysis.
|
|
Creatinine Clearance Within 3 Months Before Start of Treatment with the Study Drug
|
22.915 milliliter (mL)/minute (min)
STANDARD_DEVIATION 5.2967 • n=47 Participants • The number analyzed is the number of participants with data available for analysis.
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
Outcome measures
| Measure |
Trelagliptin 25 mg
n=83 Participants
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Adverse Drug Reactions (ADRs)
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Trelagliptin 25 mg
n=83 Participants
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Serious ADRs
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Number of participants who had one or more hypoglycemia of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Trelagliptin 25 mg
n=83 Participants
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
Serious ADRs
|
0 Participants
|
|
Number of Participants Who Had One or More Hypoglycemia of Serious ADRs and the Other ADRs
Other ADRs
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to Month 12Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
Number of participants who had one or more infection of serious ADRs and the other ADRs (non-serious ADRs) were reported. AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug. A serious adverse event is 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. Among these, events which are considered possibly associated with a medicinal product are defined as adverse drug reactions.
Outcome measures
| Measure |
Trelagliptin 25 mg
n=83 Participants
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
Serious ADRs
|
0 Participants
|
|
Number of Participants Who Had One or More Infection of Serious ADRs and the Other ADRs
Other ADRs
|
0 Participants
|
Adverse Events
Trelagliptin 25 mg
Serious events: 33 serious events
Other events: 10 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Trelagliptin 25 mg
n=83 participants at risk
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Herpes zoster
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Pneumonia
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Infections and infestations
Device related infection
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Blood and lymphatic system disorders
Nephrogenic anaemia
|
6.0%
5/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
3/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Ketoacidosis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Carotid artery stenosis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cerebral infarction
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Nervous system disorders
Cholinergic syndrome
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Cataract
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Glaucoma
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Eye disorders
Vitreous haemorrhage
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Acute myocardial infarction
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Angina pectoris
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure chronic
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Cardiac disorders
Coronary artery stenosis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asphyxia
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Enterocolitis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Neurogenic bladder
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Renal impairment
|
3.6%
3/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Renal and urinary disorders
Chronic kidney disease
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
General disorders
Death
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Fall
|
3.6%
3/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Shunt occlusion
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Injury, poisoning and procedural complications
Shunt stenosis
|
4.8%
4/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Product Issues
Device pacing issue
|
1.2%
1/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Other adverse events
| Measure |
Trelagliptin 25 mg
n=83 participants at risk
Trelagliptin 25 milligrams (mg) tablet, orally, once weekly for up to 12 months. Participants received interventions as part of routine medical care.
|
|---|---|
|
Infections and infestations
Periodontitis
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Vascular disorders
Hypertension
|
4.8%
4/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
|
Hepatobiliary disorders
Hepatic function abnorma
|
2.4%
2/83 • Up to Month 12
At each visit the investigator had to document any occurrence of AEs and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to the survey treatment.
|
Additional Information
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