Treatment Preference for Weekly Dipeptidyl Peptidase-4 (DPP-4) Inhibitors Versus Daily DPP-4 Inhibitors in Participants With Type 2 Diabetes Mellitus
NCT ID: NCT03231709
Last Updated: 2023-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2017-08-18
2018-02-09
Brief Summary
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Detailed Description
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The study enrolled 60 patients. Participants will be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups:
* Trelagliptin 100 mg, followed by Alogliptin 25 mg
* Alogliptin 25 mg, followed by Trelagliptin 100 mg All participants will be asked to take one tablet of trelagliptin orally once a week or one tablet of alogliptin orally once a day throughout the study period.
This multi-center trial will be conducted in Japan. The overall time to participate in this study is 16 weeks. Participants will make 3 visits to the clinic.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Trelagliptin 100 mg + Alogliptin 25 mg
Trelagliptin preceding group (T-A group): Trelagliptin 100 mg, tablets, orally, once a week for 8 weeks, followed by alogliptin, 25 mg, tablets, orally, once a day for 8 weeks.
Trelagliptin
Trelagliptin tablets
Alogliptin
Alogliptin tablets
Alogliptin 25 mg + Trelagliptin 100 mg
Alogliptin preceding group (A-T group): Alogliptin, 25 mg, tablets, orally, once a day for 8 weeks, followed by trelagliptin, 100 mg, tablets, orally, once a week for 8 weeks.
Trelagliptin
Trelagliptin tablets
Alogliptin
Alogliptin tablets
Interventions
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Trelagliptin
Trelagliptin tablets
Alogliptin
Alogliptin tablets
Eligibility Criteria
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Inclusion Criteria
2. Participants who are being treated with any of the following DPP-4 inhibitors for at least 8 weeks prior to the time of informed consent (Week 0).
* Sitagliptin : 50 mg once daily
* Alogliptin : 25 mg once daily
* Linagliptin : 5 mg once daily
* Teneligliptin : 20 mg once daily
* Saxagliptin : 5 mg once daily
4. Participants whose glycosylated hemoglobin (HbA1c) value measured within 8 weeks prior to the time of informed consent (Week 0) is below 10.0%.
5. Participants who responded to Diabetes Treatment Satisfaction Questionnaire (DTSQ) at the time of informed consent (Week 0).
6. Participants who were judged by the investigators capable to understand the contents of this clinical research and comply with them.
7. Participants who are able to sign and date the Informed Consent Form before any clinical research procedure begins.
8. Participants who are at least 20 years old at the time of giving the consent.
9. Participants who are classified as outpatients.
Exclusion Criteria
2. Participants who are being treated with drugs other than those for once-daily oral dosing for the purpose of treatment of chronic complication (for example, "BENET® Tablets 75 mg", a therapeutic agent for osteoporosis which is administered once monthly).
3. Participants who are being treated with twice-daily dosing of DPP-4 inhibitor (vildagliptin or anagliptin).
4. Participants who are being treated with anti-diabetic fixed-dose combination pill contained a DPP-4 inhibitor.
5. Participants with moderate or severe renal impairment (for example, participant whose estimated glomerular filtration rate (eGFR) is below 60 mL/min/1.73m\^2).
6. Participants for whom blood sugar control by insulin preparations is desired (for example, participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, or serious trauma before or after surgery).
7. Participants who have a history of hypersensitivity or allergy to DPP-4 inhibitor.
8. Participants with serious heart disease, cerebrovascular disorder, or participants with serious disease in the pancreas, blood, etc.
9. Participants with unstable proliferative diabetic retinopathy.
10. Participants with malignant tumor.
11. Participants who are pregnant, breast-feeding, possibly pregnant, or planning to become pregnant.
12. Participants participating in other clinical studies.
13. Participants who have been determined as inappropriate participants by the investigator.
20 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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OCROM Clinic
Suita, Osaka, Japan
ToCROM Clinic
Shinjuku, Tokyo, Japan
Countries
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References
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Meguro S, Matsui S, Itoh H. Treatment preference for weekly versus daily DPP-4 inhibitors in patients with type 2 diabetes mellitus: outcomes from the TRINITY trial. Curr Med Res Opin. 2019 Dec;35(12):2071-2078. doi: 10.1080/03007995.2019.1651130. Epub 2019 Aug 22.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1197-5821
Identifier Type: OTHER
Identifier Source: secondary_id
JapicCTI-173662
Identifier Type: REGISTRY
Identifier Source: secondary_id
Trelagliptin-4003
Identifier Type: -
Identifier Source: org_study_id