Type 2 Diabetes MellitusPhase 3NCT02512068
A Phase 3, Randomized, Double-blind, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study of SYR-472 (25 mg) in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
A Phase 3 study testing Trelagliptin 25 mg in people with Type 2 Diabetes Mellitus, run by Takeda at 49 sites in Japan.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- Trelagliptin 25 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 107 participants
- Where
- 49 sitesJapan
- Study dates
- 7 Aug 2015to 24 Apr 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The participant has a diagnosis of type 2 diabetes mellitus.
- The participant has a fasting C-peptide value of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a hemoglobin value of 10.0 g/dL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a Haemoglobin A1c (HbA1c) value of 7.0% or higher but less than 10.0% at Week -2 of the screening period. For participants undergoing hemodialysis (with End-stage Renal Disease [ESRD]), those with a glycoalbumin value of 20% or higher could be enrolled even if their HbA1c value is below 7.0% at Week -2 of the screening period.
- <HbA1c value of 7.0% or higher but less than 10.0% at Week -2 of the screening period> The participant has an HbA1c value difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%* of the HbA1c value at the start of the screening period (Week -6).
- <For participants undergoing hemodialysis (with ESRD), glycoalbumin value of 20% or higher and HbA1c value of below 7.0% at Week -2 of the screening period> The participant has a glycoalbumin difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0% of the glycoalbumin value at the start of the screening period (Week -6).
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- : rounded to one decimal place
- The participant has been on a fixed diet and/or exercise therapy (if any) for at least 6 weeks prior to the start of the screening period (Week -6).
- The participant meets any of the following:
- The participant has not received any antidiabetic medications (including insulin preparations) from at least 6 weeks prior to the start of the screening period (Week -6).
- The participant is being treated with one oral hypoglycemic drug* starting from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen.
- : any one of the following medications: mitiglinide calcium hydrate, repaglinide, acarbose, miglitol, or voglibose
- The participant is being treated with one insulin preparation** starting from at least 6 weeks prior to the start of the screening period (Week -6) at a fixed dose and regimen (≤40 units/day) of the insulin preparation.
- Any one of the following insulin monotherapies: mixed (short-acting or rapid-acting insulin containing no more than 30% volume), intermediate-acting, or long-acting soluble insulin preparations
- The participant is not undergoing hemodialysis or peritoneal dialysis and has severe renal impairment [creatinine clearance (Ccr) <30 mL/min at the start of the screening period (Week -6)], or the participant is undergoing hemodialysis and has end-stage renal failure.
- In the opinion of the investigator or sub-investigator, the initiation of hemodialysis or peritoneal dialysis at least within 12 weeks after starting the investigational product is not expected. [in cases where the participant is not undergoing hemodialysis or peritoneal dialysis (patients with severe renal impairment)]
- The participant has been undergoing hemodialysis starting from at least 6 months prior to informed consent and, in the opinion of the investigator or sub-investigator, the participant is clinically stable. [in cases where the participant is undergoing hemodialysis (patient with end-stage renal failure)]
- The participant is male or female and is aged 20 years or older at the time of informed consent.
- A female participant of childbearing potential who is sexually active with a nonsterilized male partner agrees to use routinely adequate contraception from signing of informed consent until one month after the end of the study.
- In the opinion of the investigator or sub-investigator, the participant is capable of understanding and complying with protocol requirements.
- The participant signs and dates a written, informed consent form prior to the initiation of any study procedures.
Who cannot join
- The participant has clinically evident hepatic impairment [e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of the screening period (Week -6) or at Week -2 of the screening period].
- The participant has any serious cardiac diseases, cerebrovascular disorders, or serious pancreatic or hematological diseases (e.g., participants who require inpatient treatment or are hospitalized for treatment within 24 weeks prior to the start of the screening period).
- The participant has severe ketosis, diabetic coma or precoma, type 1 diabetes, severe infection, before or after surgery, or severe external trauma.
- The participant has hemoglobinopathy (sickle cell disease, thalassemia, etc.).
- The participant experienced hypoglycemia (participants with a blood glucose value of ≤70 mg/dL or hypoglycemic symptoms) within 6 weeks prior to the start of the screening period or during the screening period (at least twice per week).
- The participant has inadequately controlled hypertension.
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- For participants who are being treated with one antidiabetic agent, the participant was using at least two antidiabetic therapies on the day before 6 weeks prior to the start of the screening period (Week -6) (43 days prior to the start of the screening period).
- The participant has malignancies.
- The participant has a history of hypersensitivity or allergies to dipeptidyl peptidase 4 (DPP-4) inhibitors.
- The participant has a history of gastrectomy or small intestinal resection.
- The participant is a habitual drinker and consumes a daily average of more than 100 mL of alcohol.
- The participant has a history of drug abuse (defined as the use of an illegal drug) or alcohol dependence.
- The participant is required to take excluded medications during the study period.
- The participant has previously received trelagliptin.
- The participant received any other investigational products (including study drugs in a post-marketing clinical study) within 12 weeks prior to the start of the screening period.
- The participant is participating in other clinical studies at the time of informed consent.
- If female, the participant is pregnant or lactating or intending to become pregnant from the time of informed consent to within 1 month after the end of the study; or intending to donate ova during such time period.
- The participant is an immediate family member of a study site employee, or is in a dependent relationship with a study site employee who is involved in the conduct of this study (e.g., spouse, parent, child, sibling) or may consent under duress.
- The participant is hospitalized during the screening period or is deemed as requiring hospitalization during the study period by the investigator or sub-investigator, unless the hospitalization is for short-term evaluations including complete health checkups or shunt (including shunt maintenance).
- The participant is deemed ineligible for the study for any other reason by the investigator or sub-investigator.
Trial locations and contacts
49 sites in 1 country.
49 sites in 1 country
Japan49 sites
Study site
Akita
Study site
Anjo, Aichi-ken
Study site
Asahi, Chiba
Study site
Chikushino-shi, Fukuoka
Study site
Chitose, Hokkaido
Study site
Fujisawa, Kanagawa
Study site
Fukaya, Saitama
Study site
Fukuyama, Hiroshima
Study site
Hachiōji, Tokyo
Study site
Hamamatsu, Shizuoka
Study site
Himeji, Hyōgo
Study site
Imabari, Ehime
Study site
Itabashi-ku, Tokyo
Study site
Kamakura, Kanagawa
Study site
Kasaoka, Okayama-ken
Study site
Kasuga, Fukuoka
Study site
Kasukabe, Aichi-ken
Study site
Kasuya-gun, Fukuoka
Study site
Kawasaki, Kanagawa
Study site
Kisarazu, Chiba
Study site
Kitakyushu, Fukuoka
Study site
Kumagaya, Saitama
Study site
Kumamoto
Study site
Kunitachi, Tokyo
Study site
Matsuyama, Ehime
Study site
Mito, Ibaragi
Study site
Munakata, Fukuoka
Study site
Nagano
Study site
Nagoya, Aichi-ken
Study site
Nakano, Nagano
Study site
Niigata
Study site
Niihama, Ehime
Study site
Osaka
Study site
Sakai, Ibaragi
Study site
Sendai, Miyagi
Study site
Setouchi, Okayama-ken
Study site
Shimonoseki, Yamaguchi
Study site
Tajimi, Gifu
Study site
Takarazuka, Hyōgo
Study site
Takasaki, Gunma
Study site
Toyohashi, Aichi-ken
Study site
Ube, Yamaguchi
Study site
Ueda, Nagano
Study site
Uozu, Toyama
Study site
Yamagata
Study site
Yatomi, Aichi-ken
Study site
Yokohama, Kanagawa
Study site
Yoshinogawa, Tokushima
Study site
Yotsukaidō, Chiba
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study to Evaluate the Efficacy and Safety of SYR-472 When Orally Administered at a Dose of 25 mg Once Weekly in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given); and to evaluate the long-term efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease.
Read the detailed description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparative study (Treatment Period I) and a phase 3, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of trelagliptin when administered orally at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given).
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- Trelagliptin 25 mg, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trelagliptin 25 mgDrug
Also called SYR-472
Trelagliptin 25 mg Tablets
PlaceboDrug
Placebo Tablets
| Study group | Role | What they receive |
|---|---|---|
| Trelagliptin 25 mg | Experimental | Trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II) Receives: Drug: Trelagliptin 25 mg |
| Placebo and Trelagliptin 25 mg | Experimental | Placebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II) Receives: Drug: Trelagliptin 25 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in HbA1c at the End of Treatment Period I
Measured: Baseline (Week 0) and end of Treatment Period I (Up to Week 12)
Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group.
Measured: Up to Week 12
Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for "Trelagliptin 25 mg" group and events in Period II for "Placebo and Trelagliptin 25 mg" group, was analyzed.
Measured: Up to Week 54
Secondary outcomes (7)
Changes From Baseline in HbA1c
Reported data was the change from baseline in HbA1c at each time point.
Measured: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II
Measured: At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)
Change From Baseline in Fasting Plasma Glucose
Reported data was the change from baseline in fasting plasma glucose at each time point.
Measured: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Change From Baseline in Glycoalbumin
Reported data was the change from baseline in glycoalbumin at each time point.
Measured: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II
Number of participants with a vital sign-related TEAE classified under the System Organ Class of "investigations," was reported.
Measured: Up to Week 12
Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II
Here "QTcF" is corrected QT interval by Fridericia formula.
Measured: Up to Week 12
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II
Here "U/L" is Unit/Litter, and "ULN" is Upper Limit of Normal.
Measured: Up to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2015 (estimated)
- Study start7 Aug 2015
- Primary completion24 Apr 2018
- Study completion24 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by TakedaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02512068
- Sponsor's protocol ID
- SYR-472-3003
- Other IDs
- U1111-1172-1511, JapicCTI-152970
- Status last verified
- Dec 2023
- First submitted
- 28 Jul 2015
- Last updated
- 12 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Comparative Study and a Phase 3, Multicenter, Open-label, Long-term Study to Evaluate the Efficacy and Safety of SYR-472 When Orally Administered at a Dose of 25 mg Once Weekly in Patients With Type 2 Diabetes Mellitus Complicated by Severe Renal Impairment or End-stage Renal Disease
- ClinicalTrials.gov ID
- NCT02512068
- Acronym / sponsor ID
- SYR-472-3003
- Conditions
- Type 2 Diabetes Mellitus
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2015 (actual)
- Primary completion
- 24 Apr 2018 (actual)
- Study completion
- 24 Apr 2018 (actual)
- First posted
- 30 Jul 2015 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly using placebo as a control in patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given); and to evaluate the long-term efficacy and safety of trelagliptin when administered at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease.
Detailed description
This is a phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group, comparative study (Treatment Period I) and a phase 3, multicenter, open-label, long-term study (Treatment Period II) to evaluate the efficacy and safety of trelagliptin when administered orally at a dose of 25 mg once weekly to patients with type 2 diabetes mellitus complicated by severe renal impairment or end-stage renal disease and inadequate glycemic control despite diet and/or exercise therapy (if given) or despite treatment with one antidiabetic drug in addition to diet and/or exercise therapy (if given).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trelagliptin 25 mg | Experimental | Drug: Trelagliptin 25 mgTrelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period I + II) |
| Placebo and Trelagliptin 25 mg | Experimental | Drug: Trelagliptin 25 mg, Drug: PlaceboPlacebo tablet, orally, once weekly before breakfast for up to Week 12 (Period I), followed by trelagliptin 25 mg tablet, orally, once weekly before breakfast for up to Week 52 (Period II) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- The participant has a diagnosis of type 2 diabetes mellitus.
- The participant has a fasting C-peptide value of 0.6 ng/mL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a hemoglobin value of 10.0 g/dL or higher at the start of the screening period (Week -6) and Week -2 of the screening period.
- The participant has a Haemoglobin A1c (HbA1c) value of 7.0% or higher but less than 10.0% at Week -2 of the screening period. For participants undergoing hemodialysis (with End-stage Renal Disease [ESRD]), those with a glycoalbumin value of 20% or higher could be enrolled even if their HbA1c value is below 7.0% at Week -2 of the screening period.
- <HbA1c value of 7.0% or higher but less than 10.0% at Week -2 of the screening period> The participant has an HbA1c value difference between the start of the screening period (Week -6) and Week -2 of the screening period within 10.0%* of the HbA1c value at the start of the screening period (Week -6).
Key exclusion criteria (20 listed)
- The participant has clinically evident hepatic impairment [e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥2.5 times the upper limit of normal or total bilirubin of ≥2.0 mg/dL at the start of the screening period (Week -6) or at Week -2 of the screening period].
- The participant has any serious cardiac diseases, cerebrovascular disorders, or serious pancreatic or hematological diseases (e.g., participants who require inpatient treatment or are hospitalized for treatment within 24 weeks prior to the start of the screening period).
- The participant has severe ketosis, diabetic coma or precoma, type 1 diabetes, severe infection, before or after surgery, or severe external trauma.
- The participant has hemoglobinopathy (sickle cell disease, thalassemia, etc.).
- The participant experienced hypoglycemia (participants with a blood glucose value of ≤70 mg/dL or hypoglycemic symptoms) within 6 weeks prior to the start of the screening period or during the screening period (at least twice per week).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trelagliptin 25 mgAlso: SYR-472Trelagliptin 25 mg Tablets | Drug | Placebo and Trelagliptin 25 mg, Trelagliptin 25 mg |
| PlaceboPlacebo Tablets | Drug | Placebo and Trelagliptin 25 mg |
Primary outcome
Change From Baseline in HbA1c at the End of Treatment Period I
Time frame: Baseline (Week 0) and end of Treatment Period I (Up to Week 12)
Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II
Time frame: Up to Week 12
An Adverse Event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug. Reported data is the number of participants reporting one or more TEAEs that occurred before the start of Treatment Period II in each group.
Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet
Time frame: Up to Week 54
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a drug (including the study drug). It does not necessarily have to have a causal relationship with this treatment (including the study drug). An AE can therefore be any unfavorable and unintended sign (eg, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug (including the study drug), whether or not it is considered related to the drug. A TEAE is defined as an adverse event with an onset that occurs after receiving study drug. As to collect the safety data of long-term treatment with the active drug widely, the number of participants reporting one or more TEAEs that occurred after 1st dose of trelagliptin 25 mg, that is events in Period I and II for "Trelagliptin 25 mg" group and events in Period II for "Placebo and Trelagliptin 25 mg" group, was analyzed.
7 secondary outcomes
Changes From Baseline in HbA1c
Time frame: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II
Time frame: At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)
Change From Baseline in Fasting Plasma Glucose
Time frame: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Change From Baseline in Glycoalbumin
Time frame: Baseline (Week 0) and Week 2, 4, 8, 12, and End of Treatment Period I (up to Week 12) and Period II (up to Week 52)
Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II
Time frame: Up to Week 12
Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II
Time frame: Up to Week 12
Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II
Time frame: Up to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
49 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trelagliptin 25 mg in people with Type 2 Diabetes Mellitus, run by Takeda at 49 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 49 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in HbA1c at the End of Treatment Period I (time frame: Baseline (Week 0) and end of Treatment Period I (Up to Week 12)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.