Clinical trial NCT03014479: Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
Official title: Study of the QOL Evaluation of Trelagliptin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2017-01-09
Enrollment: 219
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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. Eligible participants will be randomized to either the study drug (trelagliptin) group or the comparative drug (daily DPP-4 inhibitor) group. Treatment burden will be assessed using Diabetes Therapy Related -QOL (DTR-QOL) questionnaire and Diabetes Treatment Satisfaction Questionnaire (DTSQ).

Eligibility criteria: Inclusion Criteria:

1. Participants diagnosed as type 2 diabetes.
2. Participants with a stable diet and exercise therapy only for at least 12 weeks prior to the start of the screening period.
3. Participants who require a DPP-4 inhibitor treatment.
4. Participants with Hemoglobin A1c (HbA1c) \>=6.5 % and \<10.0 % at the start of the screening period.
5. Participants who completed DTR-QOL questionnaire at the start of the screening period.
6. Participants who have received less than 2 types of medication for treatment of comorbidities (such as hypertension or dyslipidemia) at the start of the screening period (any number of daily doses).
7. Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical study and complying with the study protocol requirements.
8. Participants who can provide the written informed consent prior to the initiation of any study procedures.
9. Participants aged \>=20 years at the time of informed consent.
10. Outpatient.

Exclusion Criteria:

1. Participants who are receiving any oral anti-diabetic medication for the treatment of type 2 diabetes at the start of the screening period.
2. Participants diagnosed with type 1 diabetes.
3. 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).
4. Participants with serious heart disease or cerebrovascular disorder, or serious pancreatic, blood, or other disease.
5. Participants with a history of gastrointestinal resection.
6. Participant with a proliferative diabetic retinopathy.
7. Participant with malignancy.
8. Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
9. Pregnant, lactating or planning pregnancy during the study period.
10. Participants who may need to add or discontinue concomitant medication or change the dose during the study period.
11. Participants who will require treatment with a prohibited concomitant medication during the study period.
12. Participants participating in other clinical studies.
13. Participants assessed ineligible in the study by the principal investigator or the investigator.

Primary outcomes:
measure: Change From Baseline in Total Score for All Question Items in the Diabetes Therapy Related -QOL (DTR-QOL) Questionnaire at the End of Study
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
Secondary outcomes:
measure: 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
timeFrame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
measure: Change From Baseline in Total Score for Each Factor Provided Through the DTR-QOL Questionnaire [Factor 3: Hypoglycemia] at Each Assessment Time Point
timeFrame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to Week 4, 12, and the end of study (Week 12)
measure: Change From Baseline in Total Score for All Question Items in the DTR-QOL Questionnaire at Each Assessment Time Point
timeFrame: Baseline (Week 0), up to Week 4, 12
measure: Change From Baseline in Total Score for Questions About Treatment Satisfaction in the Diabetes Treatment Satisfaction Questionnaire (DTSQ) at Each Assessment Time Point
timeFrame: Baseline (Week 0), up to Week 4, 12 and the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: 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
timeFrame: Baseline (Week 0), up to the end of study (Week 12)
measure: Change From Baseline in Score Per Question in the DTR-QOL Questionnaire at the End of Study
timeFrame: Baseline (Week 0), up to end of study (Week 12)
measure: Change From Baseline in Score Per Question in the the DTSQ at the End of Study
timeFrame: Baseline (Week 0), up to end of study (Week 12)
measure: Number of Participants Reporting One or More Treatment-emergent Adverse Events
timeFrame: Up to 12 weeks
measure: Number of Participants Reporting One or More Hypoglycemia
timeFrame: Up to 12 weeks
measure: Duration of Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
timeFrame: Up to 12 weeks
measure: Number of Participants With Hospitalization for Type 2 Diabetes (Excluding Educational Hospitalization Without Worsening of Diabetes)
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Takeda Selected Site 17
state: Aichi
city: Nagoya
country: Japan
facility: Takeda Selected Site 18
state: Aichi
city: Kanra
country: Japan
facility: Takeda Selected Site 25
state: Gunma
city: Kobe
country: Japan
facility: Takeda Selected Site 9
state: Hyogo
city: Koga
country: Japan
facility: Takeda Selected Site 27
state: Ibaraki
city: Kawasaki
country: Japan
facility: Takeda Selected Site 14
state: Kanagawa
city: Sagamihara
country: Japan
facility: Takeda Selected Site 11
state: Kanagawa
city: Yamato
country: Japan
facility: Takeda Selected Site 10
state: Kanagawa
city: Sendai
country: Japan
facility: Takeda Selected Site 4
state: Miyagi
city: Sendai
country: Japan
facility: Takeda Selected Site 5
state: Miyagi
city: Kashihara
country: Japan
facility: Takeda Selected Site 3
state: Nara
city: Kashiwara
country: Japan
facility: Takeda Selected Site 15
state: Osaka
city: Suita
country: Japan
facility: Takeda Selected Site 1
state: Osaka
city: Okegawa
country: Japan
facility: Takeda Selected Site 24
state: Saitama
city: Oyama
country: Japan
facility: Takeda Selected Site 26
state: Tochigi
city: Adachi-ku
country: Japan
facility: Takeda Selected Site 23
state: Tokyo
city: Chuo-ku
country: Japan
facility: Takeda Selected Site 6
state: Tokyo
city: Chuo-ku
country: Japan
facility: Takeda Selected Site 7
state: Tokyo
city: Edogawa-ku
country: Japan
facility: Takeda Selected Site 22
state: Tokyo
city: Musashino
country: Japan
facility: Takeda Selected Site 19
state: Tokyo
city: Ota-ku
country: Japan
facility: Takeda Selected Site 21
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Takeda Selected Site 12
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Takeda Selected Site 13
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Takeda Selected Site 20
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Takeda Selected Site 2
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Takeda Selected Site 8
state: Tokyo
city: Osaka
country: Japan
facility: Takeda Selected Site 16
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Ishii H, Suzaki Y, Miyata Y, Matsui S. 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. Diabetes Ther. 2019 Aug;10(4):1369-1380. doi: 10.1007/s13300-019-0643-1. Epub 2019 Jun 18.