Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGTrelagliptin
Trelagliptin tablets
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Had One or More Adverse Events | 36 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. |
| Number of Participants Who Had One or More Adverse Drug Reactions | 36 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. Adverse drug reaction refers to AE related to administered drug. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Insulin Level | Baseline, up to final assessment point (up to Month 36) | The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36). |
| Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Baseline, up to final assessment point (up to Month 36) | The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ \[fasting glucose (mg/dL) - 63\]. |
| Change From Baseline in Fasting Glucagon | Baseline, up to final assessment point (up to Month 36) | The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36). |
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Baseline, up to final assessment point (up to Month 36) | The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Baseline, up to final assessment point (up to Month 36) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Baseline, up to final assessment point (up to Month 36) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). |
| Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Baseline, up to final assessment point (up to Month 36) | The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36). |
| Change From Baseline in Fasting Blood Glucose | Baseline, up to final assessment point (up to Month 36) | The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 242 investigative sites in Japan, from 1 May 2016 to 31 October 2021.
Pre-assignment details
Participants with a historical diagnosis of type 2 diabetes mellitus were enrolled. Participants received trelagliptin as part of a routine medical care.
Participants by arm
| Arm | Count |
|---|---|
| Trelagliptin 100 mg Trelagliptin 100 mg tablet, orally, once weekly for up to 36 months. Participants received interventions as part of routine medical care. | 3,121 |
| Total | 3,121 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 77 |
Baseline characteristics
| Characteristic | Trelagliptin 100 mg | — |
|---|---|---|
| Age, Continuous | 66.8 Years STANDARD_DEVIATION 12.75 | — |
| Alcohol Classification No | 1863 Participants | — |
| Alcohol Classification Unknown | 613 Participants | — |
| Alcohol Classification Yes | 645 Participants | — |
| BMI | 24.94 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 4.217 | — |
| Creatinine Clearance Within 1 Month Before Start of Treatment with the Study Drug | 89.54 mL/minute (min) STANDARD_DEVIATION 41.618 | — |
| Duration of Type 2 Diabetes Mellitus | 7.6 Years STANDARD_DEVIATION 7.28 | — |
| Fasting Blood Glucose | 151.379 milligram (mg)/deciliter (dL) STANDARD_DEVIATION 59.8728 | — |
| Fasting Glucagon | 177.52 picogram (pg)/milliliter (mL) STANDARD_DEVIATION 55.766 | — |
| Glycosylated Hemoglobin A1c (HbA1c) [National Glycohemoglobin Standardization Program (NGSP)] | 7.38880 Percent STANDARD_DEVIATION 1.348643 | — |
| Healthcare Category Inpatient | 40 Participants | — |
| Healthcare Category Outpatient | 3081 Participants | — |
| Height | 161.1 Centimeters (cm) STANDARD_DEVIATION 9.95 | — |
| Hepatic Impairment Had Hepatic Impairment | 543 Participants | — |
| Hepatic Impairment Had No Hepatic Impairment | 2578 Participants | — |
| Medical Complications Had Medical Complications | 2512 Participants | — |
| Medical Complications Had No Medical Complications | 609 Participants | — |
| Medical History Had Medical History | 500 Participants | — |
| Medical History Had No Medical History | 2383 Participants | — |
| Medical History Unknown | 238 Participants | — |
| Predisposition to Hypersensitivity Had No Predisposition to Hypersensitivity | 2744 Participants | — |
| Predisposition to Hypersensitivity Had Predisposition to Hypersensitivity | 144 Participants | — |
| Predisposition to Hypersensitivity Unknown | 233 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 3121 Participants | — |
| Renal Impairment Had No Renal Impairment | 2739 Participants | — |
| Renal Impairment Had Renal Impairment | 382 Participants | — |
| Serum Creatinine Value Within 1 Month Before Start of Treatment with the Study Drug | 0.7717 mg/dL STANDARD_DEVIATION 0.21925 | — |
| Sex: Female, Male Female | 1870 Participants | — |
| Sex: Female, Male Male | 1251 Participants | — |
| Smoking Classification Current Smoker | 391 Participants | — |
| Smoking Classification Ex-Smoker | 637 Participants | — |
| Smoking Classification Never Smoked | 1407 Participants | — |
| Smoking Classification Unknown | 686 Participants | — |
| Weight | 65.12 Kilogram (kg) STANDARD_DEVIATION 14.293 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 24 / 3,121 |
| other Total, other adverse events | 54 / 3,121 |
| serious Total, serious adverse events | 167 / 3,121 |
Outcome results
Primary
Number of Participants Who Had One or More Adverse Drug Reactions
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.
Time frame: 36 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin 100 mg | Number of Participants Who Had One or More Adverse Drug Reactions | 96 Participants |
Primary
Number 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: 36 months
Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Trelagliptin 100 mg | Number of Participants Who Had One or More Adverse Events | 390 Participants |
Secondary
Change From Baseline in Fasting Blood Glucose
The reported data was the change in the mean value of fasting blood glucose collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 30 | -9.183 mg/dL | Standard Deviation 58.2264 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 36 | -9.928 mg/dL | Standard Deviation 55.3334 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Final Assessment Point (Up to Month 36) | -9.765 mg/dL | Standard Deviation 59.2496 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 1 | -11.733 mg/dL | Standard Deviation 50.2247 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 3 | -11.896 mg/dL | Standard Deviation 50.4982 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 6 | -13.816 mg/dL | Standard Deviation 57.8209 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 12 | -14.698 mg/dL | Standard Deviation 53.3678 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 18 | -10.999 mg/dL | Standard Deviation 55.6319 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Blood Glucose | Month 24 | -7.056 mg/dL | Standard Deviation 58.7981 |
Secondary
Change From Baseline in Fasting Glucagon
The reported data was the change in the mean value of fasting glucagon collected between baseline and timepoints (up to final assessment point: Month 36).
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 1 | -7.88 pg/mL | Standard Deviation 46.589 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 3 | -9.22 pg/mL | Standard Deviation 51.995 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 6 | 6.65 pg/mL | Standard Deviation 42.295 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 12 | -1.41 pg/mL | Standard Deviation 46.54 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 18 | 10.38 pg/mL | Standard Deviation 51.088 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 24 | -3.56 pg/mL | Standard Deviation 54.207 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 30 | 18.65 pg/mL | Standard Deviation 91.492 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Month 36 | 0.18 pg/mL | Standard Deviation 82.427 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Glucagon | Final Assessment Point (Month 36) | 4.27 pg/mL | Standard Deviation 70.248 |
Secondary
Change From Baseline in Fasting Insulin Level
The reported data was the change in the mean value of fasting insulin level collected between baseline and timepoints (up to final assessment point: Month 36).
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 1 | -7.079 microunit/milliliter (mcrU/mL) | Standard Deviation 19.5631 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 3 | -5.520 microunit/milliliter (mcrU/mL) | Standard Deviation 19.7015 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 6 | -6.999 microunit/milliliter (mcrU/mL) | Standard Deviation 18.9998 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 12 | -4.354 microunit/milliliter (mcrU/mL) | Standard Deviation 18.4697 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 18 | -4.905 microunit/milliliter (mcrU/mL) | Standard Deviation 15.3859 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 24 | -6.601 microunit/milliliter (mcrU/mL) | Standard Deviation 16.6195 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 30 | -7.114 microunit/milliliter (mcrU/mL) | Standard Deviation 17.3951 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Month 36 | -5.740 microunit/milliliter (mcrU/mL) | Standard Deviation 18.2392 |
| Trelagliptin 100 mg | Change From Baseline in Fasting Insulin Level | Final Assessment Point (Up to Month 36) | -4.675 microunit/milliliter (mcrU/mL) | Standard Deviation 15.9822 |
Secondary
Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta)
The reported data was the change in the mean value of HOMA-beta. HOMA-beta measures as following; HOMA-beta = fasting insulin (microU/mL) ×360/ \[fasting glucose (mg/dL) - 63\].
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 1 | -26.523 Percent | Standard Deviation 106.9238 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 3 | -21.155 Percent | Standard Deviation 116.4317 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 6 | -23.442 Percent | Standard Deviation 107.4707 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 12 | -16.312 Percent | Standard Deviation 104.6056 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 18 | -21.949 Percent | Standard Deviation 104.5351 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 24 | -34.083 Percent | Standard Deviation 102.0591 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 30 | -39.639 Percent | Standard Deviation 120.454 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Month 36 | -31.484 Percent | Standard Deviation 129.2697 |
| Trelagliptin 100 mg | Change From Baseline in Homeostasis Model Assessment of Beat-cell Function (HOMA-beta) | Final Assessment Point (Up to Month 36) | -19.551 Percent | Standard Deviation 106.4136 |
Secondary
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c)
The reported data was the change in the mean value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected between baseline and timepoints (up to final assessment point: Month 36). A negative change from baseline indicates improvement.
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 1 | -0.24813 Percent | Standard Deviation 0.682526 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 3 | -0.40573 Percent | Standard Deviation 1.136176 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 6 | -0.43716 Percent | Standard Deviation 1.173372 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 12 | -0.44281 Percent | Standard Deviation 1.131737 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 18 | -0.33933 Percent | Standard Deviation 1.181299 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 24 | -0.34909 Percent | Standard Deviation 1.194628 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 30 | -0.33164 Percent | Standard Deviation 1.194041 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Month 36 | -0.35018 Percent | Standard Deviation 1.197507 |
| Trelagliptin 100 mg | Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) | Final Assessment Point (Up to Month 36) | -0.33498 Percent | Standard Deviation 1.328413 |
Secondary
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 6.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Baseline | 6.0 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 1 | 6.8 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 3 | 8.7 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 6 | 9.8 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 12 | 11.0 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 18 | 8.2 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 24 | 8.1 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 30 | 9.3 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Month 36 | 11.2 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 6.0 Percent) | Final Assessment Point (Up to Month 36) | 11.3 Percent |
Secondary
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 7.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Baseline | 44.3 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 1 | 50.3 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 3 | 58.4 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 6 | 60.9 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 12 | 62.5 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 18 | 58.5 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 24 | 60.0 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 30 | 59.7 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Month 36 | 63.1 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 7.0 Percent) | Final Assessment Point (Up to Month 36) | 58.0 Percent |
Secondary
Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent)
The reported data was percentage of participants who achieved good glycemic control (defined as reduction in HbA1c values \< 8.0 Percent) at baseline and timepoints (up to final assessment point: Month 36).
Time frame: Baseline, up to final assessment point (up to Month 36)
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 | Group | Value (NUMBER) |
|---|---|---|---|
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Baseline | 78.0 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 1 | 81.9 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 3 | 86.1 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 6 | 87.3 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 12 | 88.8 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 18 | 87.5 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 24 | 88.1 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 30 | 88.4 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Month 36 | 89.3 Percent |
| Trelagliptin 100 mg | Percentage of Participants Achieving Good Glycemic Control (Reduction in HbA1c Values < 8.0 Percent) | Final Assessment Point (Up to Month 36) | 84.6 Percent |