Type 2 Diabetes Mellitus
Conditions
Keywords
Drug Therapy
Brief summary
The purpose of this survey is to examine the safety and efficacy of long-term use of alogliptin/pioglitazone(Liovel) combination tablets in patients with type 2 diabetes mellitus determined as warranting combination therapy with alogliptin benzoate and pioglitazone hydrochloride
Detailed description
This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting. Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000. The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.
Interventions
DRUGAlogliptin/Pioglitazone
Alogliptin/Pioglitazone combination tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with type 2 diabetes mellitus
Exclusion criteria
* Patients meeting any of the following criteria will be excluded: 1. Patients with current cardiac failure or a past history of cardiac failure 2. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus 3. Patients with serious hepatic dysfunction 4. Patients with serious renal dysfunction 5. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury 6. Patients with a history of hypersensitivity to any ingredients of Alogliptin/Pioglitazone 7. Pregnant or possibly pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience at Least One Adverse Events | Up to 12 Months | — |
| Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) | Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes From Baseline in Fasting Blood Glucose (FBG) | Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months) | Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months). |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the study at 445 investigative sites in Japan, from 28 November 2011 to 31 March 2015.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled to receive Alogliptin/Pioglitazone 25 milligram (mg)/ 15 mg or 25 mg / 30 mg combination tablet orally, once daily for up to 12 months.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin/Pioglitazone Alogliptin/Pioglitazone 25 mg/ 15 mg or 25 mg/ 30 mg combination tablet, orally, once daily for up to 12 months in participants based upon the disease severity. Participants received interventions as part of routine medical care. | 3,139 |
| Total | 3,139 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 89 |
| Overall Study | Protocol Deviation | 53 |
Baseline characteristics
| Characteristic | Alogliptin/Pioglitazone |
|---|---|
| Age, Continuous | 64.7 Years STANDARD_DEVIATION 11.78 |
| Alogliptin Status Had Doses of Alogliptin | 1047 Participants |
| Alogliptin Status Had No Doses of Alogliptin | 2092 Participants |
| BMI | 26.49 kg/m^2 STANDARD_DEVIATION 4.592 |
| Concomitant Allergic Condition Had Concomitant Allergic Condition | 185 Participants |
| Concomitant Allergic Condition Had No Concomitant Allergic Condition | 2954 Participants |
| Concomitant Cardiac Disease Had Concomitant Cardiac Disease | 311 Participants |
| Concomitant Cardiac Disease Had No Concomitant Cardiac Disease | 2828 Participants |
| Concomitant Heart Failure Had Concomitant Heart Failure | 5 Participants |
| Concomitant Heart Failure Had No Concomitant Heart Failure | 3134 Participants |
| Concomitant Hepatic Disorder Had Concomitant Hepatic Disorder | 477 Participants |
| Concomitant Hepatic Disorder Had No Concomitant Hepatic Disorder | 2662 Participants |
| Concomitant Lifestyle-Related Disease Had Concomitant Lifestyle-Related Disease | 2556 Participants |
| Concomitant Lifestyle-Related Disease Had No Concomitant Lifestyle-Related Disease | 583 Participants |
| Concomitant Malignant Tumor Had Concomitant Malignant Tumor | 47 Participants |
| Concomitant Malignant Tumor Had No Concomitant Malignant Tumor | 3092 Participants |
| Concomitant Renal Disorder Had Concomitant Renal Disorder | 379 Participants |
| Concomitant Renal Disorder Had No Concomitant Renal Disorder | 2760 Participants |
| Concomitant Stroke-Related Disease Had Concomitant Stroke-Related Disease | 160 Participants |
| Concomitant Stroke-Related Disease Had No Concomitant Stroke-Related Disease | 2979 Participants |
| Degree of Hepatic Dysfunction Grade 1 | 216 Participants |
| Degree of Hepatic Dysfunction Grade 2 | 40 Participants |
| Degree of Hepatic Dysfunction Grade 3 | 1 Participants |
| Degree of Hepatic Dysfunction Normal | 1765 Participants |
| Degree of Hepatic Dysfunction Unknown | 1117 Participants |
| Degree of Renal Dysfunction (Cr) Moderate | 49 Participants |
| Degree of Renal Dysfunction (Cr) Normal or Mild | 1933 Participants |
| Degree of Renal Dysfunction (Cr) Severe | 2 Participants |
| Degree of Renal Dysfunction (Cr) Unknown | 1155 Participants |
| Degree of Renal Dysfunction (eGFR) Mild | 1090 Participants |
| Degree of Renal Dysfunction (eGFR) Moderate | 411 Participants |
| Degree of Renal Dysfunction (eGFR) Normal | 462 Participants |
| Degree of Renal Dysfunction (eGFR) Severe | 21 Participants |
| Degree of Renal Dysfunction (eGFR) Unknown | 1155 Participants |
| Diabetic Complications Had No Presence of Diabetic Complications | 2621 Participants |
| Diabetic Complications Had Presence of Diabetic Complications | 518 Participants |
| Drinking Habits Current Drinker | 900 Participants |
| Drinking Habits Never Drank or Ex Drinker | 1538 Participants |
| Drinking Habits Unknown | 701 Participants |
| Duration of Type 2 Diabetes Mellitus | 7.56 Years STANDARD_DEVIATION 6.95 |
| Haemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | 7.63 Percent HbA1c STANDARD_DEVIATION 1.276 |
| Healthcare Category Inpatient | 26 Participants |
| Healthcare Category Outpatient | 3113 Participants |
| Medical Complications Had No Presence of Medical Complications | 441 Participants |
| Medical Complications Had Presence of Medical Complications | 2698 Participants |
| Medical History Had No Presence of Medical History | 2523 Participants |
| Medical History Had Presence of Medical History | 347 Participants |
| Medical History Unknown | 269 Participants |
| New York Heart Association (NYHA) Heart Failure Classification Class I | 3 Participants |
| New York Heart Association (NYHA) Heart Failure Classification Class II | 1 Participants |
| Pioglitazone Status Had Doses of Pioglitazone | 1737 Participants |
| Pioglitazone Status Had No Doses of Pioglitazone | 1402 Participants |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 2735 Participants |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 119 Participants |
| Predisposition to Hypersensitivity Unknown | 285 Participants |
| Pregnancy Status (Not Pregnant) | 1188 Participants |
| Region of Enrollment Japan | 3139 Participants |
| Sex: Female, Male Female | 1188 Participants |
| Sex: Female, Male Male | 1951 Participants |
| Smoking Classification Current Smoker | 480 Participants |
| Smoking Classification Ex-Smoker | 557 Participants |
| Smoking Classification Never Smoked | 1260 Participants |
| Smoking Classification Unknown | 842 Participants |
| Waist Circumference (Female) <90cm | 146 Participants |
| Waist Circumference (Female) ≥90cm | 128 Participants |
| Waist Circumference (Female) Unknown | 914 Participants |
| Waist Circumference (Male) <85 centimeter (cm) | 108 Participants |
| Waist Circumference (Male) ≥85cm | 317 Participants |
| Waist Circumference (Male) Unknown | 1526 Participants |
| Weight | 68.87 kilograms (kg) STANDARD_DEVIATION 15.094 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 56 / 3,139 |
| serious Total, serious adverse events | 4 / 3,139 |
Outcome results
Primary
Changes From Baseline in Glycosylated Hemoglobin (HbA1c)
Reported data are changes in HbA1c from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).
Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin/Pioglitazone | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c at Month 1 | -0.26 Percent HbA1c | Standard Deviation 0.651 |
| Alogliptin/Pioglitazone | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c at Month 3 | -0.58 Percent HbA1c | Standard Deviation 0.991 |
| Alogliptin/Pioglitazone | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c at Month 6 | -0.66 Percent HbA1c | Standard Deviation 1.081 |
| Alogliptin/Pioglitazone | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c at Month 12 | -0.66 Percent HbA1c | Standard Deviation 1.098 |
| Alogliptin/Pioglitazone | Changes From Baseline in Glycosylated Hemoglobin (HbA1c) | Change in HbA1c at Final Assessment | -0.65 Percent HbA1c | Standard Deviation 1.121 |
Primary
Number of Participants Who Experience at Least One Adverse Events
Time frame: Up to 12 Months
Population: The safety analysis set was defined as all participants who were enrolled and completed the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Alogliptin/Pioglitazone | Number of Participants Who Experience at Least One Adverse Events | 206 Participants |
Secondary
Changes From Baseline in Fasting Blood Glucose (FBG)
Reported data are changes in fasting blood glucose level from baseline at Month 1, 3, 6, 12 and final assessment (up to 12 months).
Time frame: Baseline and Month 1, 3, 6, 12 and final assessment (up to 12 Months)
Population: The efficacy assessment population was defined as participants who completed the study and had efficacy data at baseline and post-baseline time points available. The number analyzed is the number of participants with data available for analysis at the given time-point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Alogliptin/Pioglitazone | Changes From Baseline in Fasting Blood Glucose (FBG) | Change in FBG at Month 1 | -14.7 mg/dL | Standard Deviation 49.34 |
| Alogliptin/Pioglitazone | Changes From Baseline in Fasting Blood Glucose (FBG) | Change in FBG at Month 3 | -18.7 mg/dL | Standard Deviation 50.24 |
| Alogliptin/Pioglitazone | Changes From Baseline in Fasting Blood Glucose (FBG) | Change in FBG at Month 6 | -18.4 mg/dL | Standard Deviation 50.51 |
| Alogliptin/Pioglitazone | Changes From Baseline in Fasting Blood Glucose (FBG) | Change in FBG at Month 12 | -19.6 mg/dL | Standard Deviation 50.93 |
| Alogliptin/Pioglitazone | Changes From Baseline in Fasting Blood Glucose (FBG) | Change in FBG at Final Assessment | -19.8 mg/dL | Standard Deviation 53.31 |