Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.
Detailed description
The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more). This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600. This multi-center observational trial will be conducted in Japan.
Interventions
DRUGAlogliptin and Metformin hydrochloride
Alogliptin and Metformin hydrochloride combination tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants should meet one or more of the following: 1. Have renal impairment (mild) 2. Have hepatic impairment (mild or moderate) 3. Elderly (aged 65 years or more)
Exclusion criteria
* Participants with any contraindication for study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Who Had One or More Adverse Events | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Hemoglobin (HbA1c) | Baseline, up to final assessment point (up to Month 12) | 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 12) relative to baseline. |
| Change From Baseline in Fasting Blood Glucose | Baseline, up to final assessment point (up to Month 12) | The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline. |
| Change From Baseline in Fasting Insulin Level | Baseline, up to final assessment point (up to Month 12) | The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 115 investigative sites in Japan, from 28 February 2017 to 31 October 2019.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus with renal or hepatic impairment or advanced age were enrolled. Participants received alogliptin and metformin hydrochloride combination tablets as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Alogliptin and Metformin Hydrochloride Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care. | 1,011 |
| Total | 1,011 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Case Report Forms Uncollected | 2 |
| Overall Study | Protocol Deviation | 13 |
Baseline characteristics
| Characteristic | Alogliptin and Metformin Hydrochloride | — |
|---|---|---|
| Age, Continuous | 68.0 Years STANDARD_DEVIATION 11.33 | — |
| Alogliptin-Equivalent Dose per Day Given Immediate Before the Study Drug > 25 mg | 1 Participants | — |
| Alogliptin-Equivalent Dose per Day Given Immediate Before the Study Drug 25 mg | 561 Participants | — |
| Alogliptin-Equivalent Dose per Day Given Immediate Before the Study Drug < 25 milligrams (mg) | 14 Participants | — |
| BMI | 25.47 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.996 | — |
| Combination of Drugs for Type 2 Diabetes Mellitus Other than Alogliptin or Metformin Combined | 610 Participants | — |
| Combination of Drugs for Type 2 Diabetes Mellitus Other than Alogliptin or Metformin Not Combined | 401 Participants | — |
| Drinking Habits No | 570 Participants | — |
| Drinking Habits Unknown | 195 Participants | — |
| Drinking Habits Yes | 246 Participants | — |
| Duration of Diagnosis of Type 2 Diabetes Mellitus | 8.64 Years STANDARD_DEVIATION 7.297 | — |
| Employment Status Employed | 390 Participants | — |
| Employment Status Not Employed | 495 Participants | — |
| Employment Status Unknown | 126 Participants | — |
| Healthcare Category Inpatient | 5 Participants | — |
| Healthcare Category Outpatient | 1006 Participants | — |
| Hemoglobin A1c (HbA1c) Level | 7.336 Percent STANDARD_DEVIATION 1.071 | — |
| Hepatic Impairment Had Hepatic Impairment | 466 Participants | — |
| Hepatic Impairment Had No Hepatic Impairment | 545 Participants | — |
| Medical Complications Had Medical Complications | 955 Participants | — |
| Medical Complications Had No Medical Complications | 56 Participants | — |
| Medical History Had Medical History | 267 Participants | — |
| Medical History Had No Medical History | 629 Participants | — |
| Medical History Unknown | 115 Participants | — |
| Metformin-Equivalent Dose per Day Given Immediately Before the Study Drug < 500 mg | 36 Participants | — |
| Metformin-Equivalent Dose per Day Given Immediately Before the Study Drug > 500 mg | 189 Participants | — |
| Metformin-Equivalent Dose per Day Given Immediately Before the Study Drug 500 mg | 505 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 826 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 82 Participants | — |
| Predisposition to Hypersensitivity Unknown | 103 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 1011 Participants | — |
| Renal Impairment Had No Renal Impairment | 638 Participants | — |
| Renal Impairment Had Renal Impairment | 373 Participants | — |
| Sex: Female, Male Female | 402 Participants | — |
| Sex: Female, Male Male | 609 Participants | — |
| Smoking Classification Current Smoker | 156 Participants | — |
| Smoking Classification Ex-Smoker | 216 Participants | — |
| Smoking Classification Never Smoked | 417 Participants | — |
| Smoking Classification Unknown | 222 Participants | — |
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug < 50% | 17 Participants | — |
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug ≥ 50% and < 70% | 8 Participants | — |
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug ≥ 70% and < 90% | 46 Participants | — |
| Status of Treatment Compliance to Alogliptin Medication Within 3 Months prior to the Study Drug ≥ 90% | 487 Participants | — |
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug < 50% | 15 Participants | — |
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug ≥ 50% and < 70% | 17 Participants | — |
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug ≥ 70% and < 90% | 67 Participants | — |
| Status of Treatment Compliance to Metformin Medication Within 3 Months prior to the Study Drug ≥ 90% | 618 Participants | — |
| Weight | 66.13 Kilograms (kg) STANDARD_DEVIATION 13.64 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 1,011 |
| other Total, other adverse events | 13 / 1,011 |
| serious Total, serious adverse events | 4 / 1,011 |
Outcome results
Primary
Percentage of Participants Who Had One or More Adverse Events
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.
Time frame: Up to 12 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Alogliptin and Metformin Hydrochloride | Percentage of Participants Who Had One or More Adverse Events | 5.93 Percentage of Participants |
Secondary
Change From Baseline in Fasting Blood Glucose
The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin and Metformin Hydrochloride | Change From Baseline in Fasting Blood Glucose | -12.08 milligram/deciliter (mg/dL) | Standard Deviation 46.784 |
Secondary
Change From Baseline in Fasting Insulin Level
The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin and Metformin Hydrochloride | Change From Baseline in Fasting Insulin Level | 1.21 microunit/milliliter (mcrU/mL) | Standard Deviation 13.852 |
Secondary
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 12) relative to baseline.
Time frame: Baseline, up to final assessment point (up to Month 12)
Population: Efficacy assessment population, The efficacy assessment population was defined as participants who completed the survey and had efficacy data at baseline and post-baseline time points available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Alogliptin and Metformin Hydrochloride | Change From Baseline in Glycosylated Hemoglobin (HbA1c) | -0.259 Percent | Standard Deviation 0.9633 |