Phase 4
Completed N=219
Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03014479 ↗Enrolled (actual)
219
Serious AEs
0.9%
Results posted
Feb 2019
Primary outcomePrimary: Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study — 8.72; 6.35 Units on a Scale — p=0.2305
◆ Published Evidence
Emerging
9citations · ~1 / year
Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor.
Summary
The purpose of this study is to assess the reduction in treatment burden during 12 weeks of trelagliptin administration in patients with type 2 diabetes on diet and exercise therapy only.
Linked Publications
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Randomized Multicenter Evaluation of Quality of Life and Treatment Satisfaction in Type 2 Diabetes Patients Receiving Once-Weekly Trelagliptin Versus a Daily Dipeptidyl Peptidase-4 Inhibitor.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study |
8.72; 6.35 | 0.2305 |
| SECONDARY Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 1: Burden on Social Activities and Daily Activities] at Each Assessment Time Point |
11.24; 7.83; 10.98; 9.12; 10.79; 8.92 | 0.4536 |
| SECONDARY Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 2: Anxiety and Dissatisfaction With Treatments] at Each Assessment Time Point |
5.18; 0.39; 5.94; 2.18; 6.23; 2.10 | 0.0896 |
| SECONDARY Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point |
6.15; 4.87; 5.85; 7.38; 6.06; 6.67 | 0.8506 |
| SECONDARY Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 4: Satisfaction With Treatment] at Each Assessment Time Point |
5.24; 3.85; 8.53; 6.71; 8.86; 6.17 | 0.3533 |
| SECONDARY Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point |
8.04; 4.82; 8.58; 6.63 | — |
| SECONDARY Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point |
3.1; 1.7; 3.1; 2.9; 3.1; 2.5 | 0.5451 |
| SECONDARY Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline |
6.46; 5.80; 10.60; 6.68 | — |
| SECONDARY Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Use of Medication for Treatment of Comorbidities at Baseline |
1.7; 1.2; 4.3; 3.3 | — |
| SECONDARY Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline |
6.26; 5.57; 8.76; 10.34 | — |
| SECONDARY Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Daily Doses of Medication for Treatment of Comorbidities (<2 Times or ≥2 Times) at Baseline |
1.3; 1.2; 6.8; 2.0 | — |
| SECONDARY Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline |
5.72; 6.00; 11.88; 3.26 | — |
| SECONDARY Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Total Number of Daily Tablets of Medication for Treatment of Comorbidities (<2 Tablets or ≥2 Tablets) at Baseline |
1.1; 1.2; 6.3; 1.7 | — |
| SECONDARY Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline |
8.72; 6.90; -0.50 | — |
| SECONDARY Change From Baseline in Total Score for Questions About Treatment Satisfaction in the DTSQ at the End of Study Stratified by the Number of Doses of the Study Drug or Comparative Drug (Once Weekly, Once Daily or Twice Daily) at Baseline |
3.1; 2.8; -0.5 | — |
| SECONDARY Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study |
0.9; 0.5; 1.0; 0.7; 0.5; 0.2 | — |
| SECONDARY Change From Baseline in Score Per Question in the the DTSQ at the End of Study |
0.7; 0.6; -0.4; -0.5; 0.0; -0.2 | — |
| SECONDARY Number of Participants Reporting One or More Treatment-emergent Adverse Events |
19; 20 | — |
| SECONDARY Number of Participants Reporting One or More Hypoglycemia |
0; 0 | — |
| SECONDARY Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) |
— | — |
| SECONDARY Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes) |
0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants diagnosed as type 2 diabetes.
- Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
- Participants who require a DPP-4 inhibitor treatment.
- Participants with Hemoglobin A1c (HbA1c) >=6.5 % and =20 years at the time of informed consent.
- Outpatient.
Exclusion Criteria
- Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
- Participants diagnosed with type 1 diabetes.
- Participants with severe renal impairment or renal failure (e.g., estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m^2 or on dialysis).
- Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
- Participants with a history of gastrointestinal resection.
- Participant with a proliferative diabetic retinopathy.
- Participant with malignancy.
- Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
- Pregnant, lactating or planning pregnancy during the study period.
- Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
- Participants who will require treatment with a prohibited concomitant medication during the study period.
- Participants participating in other clinical studies.
- Participants assessed ineligible in the study by the principal investigator or the investigator.
Data sourced from ClinicalTrials.gov (NCT03014479) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.