Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.
Detailed description
This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting. Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000. The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.
Interventions
DRUGAlogliptin
Alogliptin tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
-Patients with Haemoglobin A1c (HbA1c) \[Japan Diabetes Society (JDS) value\] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.
Exclusion criteria
-Patients contraindicated for alogliptin. 1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus. 2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury. 3. Patients with a history of hypersensitivity to any ingredient of alogliptin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to Month 36 | — |
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, and final assessment point (up to Month 36) | 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 final assessment point (up to Month 36) relative to baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose | Baseline, and final assessment point (up to Month 36) | The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 1406 investigative sites in Japan, from 03 August 2011 to 31 July 2017.
Pre-assignment details
Participants with a historical diagnosis of mild type 2 diabetes mellitus were enrolled. Participants received interventions as part of routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin 25 mg Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. | 18,249 |
| Total | 18,249 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 888 |
| Overall Study | Data Reliability was not Assured | 5 |
| Overall Study | Protocol Deviation | 50 |
Baseline characteristics
| Characteristic | Alogliptin 25 mg | — |
|---|---|---|
| Age, Continuous | 67.3 Years STANDARD_DEVIATION 11.41 | — |
| BMI | 24.95 kg/meter (m)^2 STANDARD_DEVIATION 4.067 | — |
| Concomitant Allergic Condition Had Concomitant Allergic Condition | 1025 Participants | — |
| Concomitant Allergic Condition Had No Concomitant Allergic Condition | 17224 Participants | — |
| Concomitant Cardiac Disease Had Concomitant Cardiac Disease | 2217 Participants | — |
| Concomitant Cardiac Disease Had No Concomitant Cardiac Disease | 16032 Participants | — |
| Concomitant Diabetes Mellitus Had Concomitant Diabetes Mellitus | 2084 Participants | — |
| Concomitant Diabetes Mellitus Had No Concomitant Diabetes Mellitus | 16165 Participants | — |
| Concomitant Heart Failure Had Concomitant Heart Failure | 540 Participants | — |
| Concomitant Heart Failure Had No Concomitant Heart Failure | 17709 Participants | — |
| Concomitant Hepatic Disorder Had Concomitant Hepatic Disorder | 1983 Participants | — |
| Concomitant Hepatic Disorder Had No Concomitant Hepatic Disorder | 16266 Participants | — |
| Concomitant Hyperlipidemia Had Concomitant Hyperlipidemia | 10946 Participants | — |
| Concomitant Hyperlipidemia Had No Concomitant Hyperlipidemia | 7303 Participants | — |
| Concomitant Hypertension Had Concomitant Hypertension | 11485 Participants | — |
| Concomitant Hypertension Had No Concomitant Hypertension | 6764 Participants | — |
| Concomitant Hyperuricaemia Had Concomitant Hyperuricaemia | 1635 Participants | — |
| Concomitant Hyperuricaemia Had No Concomitant Hyperuricaemia | 16614 Participants | — |
| Concomitant Malignant Tumor Had Concomitant Malignant Tumor | 417 Participants | — |
| Concomitant Malignant Tumor Had No Concomitant Malignant Tumor | 17832 Participants | — |
| Concomitant Renal Disorder Had Concomitant Renal Disorder | 1677 Participants | — |
| Concomitant Renal Disorder Had No Concomitant Renal Disorder | 16572 Participants | — |
| Concomitant Stroke-Related Disease Had Concomitant Stroke-Related Disease | 1177 Participants | — |
| Concomitant Stroke-Related Disease Had No Concomitant Stroke-Related Disease | 17072 Participants | — |
| Degree of Renal Dysfunction Mild | 2766 Participants | — |
| Degree of Renal Dysfunction Moderate | 598 Participants | — |
| Degree of Renal Dysfunction Normal | 14808 Participants | — |
| Degree of Renal Dysfunction Severe | 77 Participants | — |
| Dietary Instruction Instructed | 15433 Participants | — |
| Dietary Instruction Not Instructed | 2816 Participants | — |
| Drinking Habits No | 9156 Participants | — |
| Drinking Habits Unknown | 3653 Participants | — |
| Drinking Habits Yes | 5440 Participants | — |
| Duration of Diagnosis of Type 2 Diabetes Mellitus | 6.03 Years STANDARD_DEVIATION 6.452 | — |
| Exercise Instruction Instructed | 13909 Participants | — |
| Exercise Instruction Not Instructed | 4340 Participants | — |
| Healthcare Category Inpatient | 180 Participants | — |
| Healthcare Category Outpatient | 18069 Participants | — |
| Height | 159.6 Centimeters (cm) STANDARD_DEVIATION 9.61 | — |
| Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP) Value] | 6.88 Percentage of HbA1c STANDARD_DEVIATION 0.591 | — |
| Medical Complications Had No Presence of Medical Complications | 2322 Participants | — |
| Medical Complications Had Presence of Medical Complications | 15927 Participants | — |
| Medical History Had Medical History | 2080 Participants | — |
| Medical History Had No Medical History | 14497 Participants | — |
| Medical History Unknown | 1672 Participants | — |
| New York Heart Association (NYHA) Heart Failure Classification Class I | 354 Participants | — |
| New York Heart Association (NYHA) Heart Failure Classification Class II | 143 Participants | — |
| New York Heart Association (NYHA) Heart Failure Classification Class III | 26 Participants | — |
| New York Heart Association (NYHA) Heart Failure Classification Class IV | 7 Participants | — |
| New York Heart Association (NYHA) Heart Failure Classification Unknown | 10 Participants | — |
| Number of Females who were not Pregnant | 7970 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 15551 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 795 Participants | — |
| Predisposition to Hypersensitivity Unknown | 1903 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 18249 Participants | — |
| Sex: Female, Male Female | 7970 Participants | — |
| Sex: Female, Male Male | 10279 Participants | — |
| Smoking Classification Current Smoker | 2330 Participants | — |
| Smoking Classification Ex-Smoker | 3326 Participants | — |
| Smoking Classification Never Smoked | 8089 Participants | — |
| Smoking Classification Unknown | 4504 Participants | — |
| Weight | 63.85 Kilograms (kg) STANDARD_DEVIATION 13.324 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 20 / 18,249 |
| other Total, other adverse events | 41 / 18,249 |
| serious Total, serious adverse events | 65 / 18,249 |
Outcome results
Primary
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
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 final assessment point (up to Month 36) relative to baseline.
Time frame: Baseline, and final assessment point (up to Month 36)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 25 mg | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | -0.14 Percent HbA1c | Standard Deviation 0.777 |
Primary
Percentage of Participants Who Had One or More Adverse Events
Time frame: Up to Month 36
Population: Safety Analysis Set; The safety analysis set was defined as all participants who completed the study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alogliptin 25 mg | Percentage of Participants Who Had One or More Adverse Events | 10.54 Percentage of Participants |
Secondary
Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose level collected at final assessment point (up to Month 36) relative to baseline.
Time frame: Baseline, and final assessment point (up to Month 36)
Population: The efficacy assessment population was defined as participants who completed the study and had available efficacy data at baseline and post baseline. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin 25 mg | Change From Baseline in Fasting Blood Glucose | -5.8 Milligram (mg)/ deciliter (dL) | Standard Deviation 34.33 |