Type 2 Diabetes MellitusPhase 4TRACKNCT02771093

An Exploratory Study of the Effects of Trelagliptin and Alogliptin on Glucose Variability in Patients With Type 2 Diabetes Mellitus

A Phase 4 study testing Trelagliptin and Alogliptin in people with Type 2 Diabetes Mellitus, run by Takeda at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This is a multi-center, randomized, open-label, parallel-group comparative, exploratory study to evaluate the effect of trelagliptin administered at a dose of 100 mg once weekly or alogliptin administered at a dose of 25 mg once daily for 4 weeks on glycemic variation in patients with type 2 diabetes mellitus using… 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 and Alogliptin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 27 participants
Where: 1 siteJapan
Study dates: 8 Sep 2016to 27 Apr 2017
Phase: Phase 4
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

Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
Participants diagnosed with type 2 diabetes mellitus.
Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.
Participants receiving stable dietetic therapy and exercise therapy (if performed) for ≥ 4 weeks before the start of the observation period.
Participants, who in the opinion of the principal investigator or the investigator, does not have to change (including discontinuation or interruption) 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors or add new HMG-CoA reductase inhibitors during treatment period.
Men or women aged 20 years or older at the time of informed consent.

Who cannot join

Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).
Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).
Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.
Participants with a history of gastric or small intestinal resection.

Show all 18Show fewer

Participants with proliferative diabetic retinopathy.
Participants warranting insulin therapy for glycemic control (e.g., participants with severe ketosis, diabetic coma or precoma, type 1 diabetes mellitus, severe infection, perioperative participants, or serious trauma).
Participants with a history of hypersensitivity or allergy to DPP-4 inhibitors.
Participants who experience an allergic reaction to metal during CGM at the start of the observation period (Day -2).
Participants with any malignant tumors.
Habitual drinkers whose average daily alcohol consumption is > 100 mL.
Participants who have any contraindications for the study drug or are taking any contraindicated concomitant drugs listed in the package insert.
Participants anticipated to require any prohibited concomitant medications during the study period.
Participants who are day and night lifestyle reversal.
Participants participating in any other clinical studies at the time of informed consent for this study.
Pregnant women, nursing mothers, women who are possible pregnant, or women who plan to become pregnant.
Other participants who are considered inappropriate for participation in this study in the opinion of the principal investigator or investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Study site
Naka, Ibaragi

Other trials in Japan

About this study

Official title: An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus

Read the detailed description

The purpose of this study is to evaluate the effect of trelagliptin administered orally at a dose of 100 mg once weekly or alogliptin administered orally at a dose of 25 mg once daily for 4 weeks on glycemic variation in an exploratory manner as a primary objective and to evaluate the effect of difference method of administration of Dipeptidyl-peptidase (DPP)-4 on glycemic variation as secondary objective.

Conditions: Type 2 Diabetes Mellitus
Being tested: Trelagliptin, Alogliptin
Keywords: Type 2, Diabetes, Diabetes Mellitus
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.

TrelagliptinDrug
Trelagliptin 100 mg tablet
AlogliptinDrug
Alogliptin 25 mg tablet

Study groups in NCT02771093
Study group	Role	What they receive
Trelagliptin 100 mg group	Experimental	Trelagliptin 100 mg once weekly taken orally before breakfast Receives: Drug: Trelagliptin
Alogliptin 25 mg group	Experimental	Alogliptin 25 mg once daily taken orally before breakfast Receives: Drug: Alogliptin

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.
Measured: Baseline, up to 28 days

Secondary outcomes (23)

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (180 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (110 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (140 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in AUC for blood glucose when specific blood glucose levels (160 mg/dL) were observed during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 140 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 160 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Change from baseline in cumulative time during periods when blood glucose levels reached 180 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels was less than 70 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Change from baseline in peak postprandial glucose levels during the 3 hour time period after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Change from baseline in maximum variation of glucose levels between before and after breakfast, lunch and evening meal at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Change from baseline in MAGE at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Mean 24-hour Blood Glucose Levels
Change from baseline in mean 24-hour blood glucose levels at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Mean Daytime Blood Glucose Levels
Change from baseline in mean daytime blood glucose levels at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in Mean Nocturnal Blood Glucose Levels
Change from baseline in mean nocturnal blood glucose levels at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose
Change from baseline in AUC for blood glucose levels at each time points was calculated.
Measured: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Change from baseline in AUC for blood glucose during periods when blood glucose levels reached 110 mg/dL at each time points was calculated.
Measured: Baseline, up to 28 days
Standard Deviation (SD) of 24-hour Blood Glucose Values
Measured: Baseline, up to 28 days
Changes From Baseline in the SD of Daytime Blood Glucose Values
Change from baseline in SD of daytime blood glucose values at each time points was calculated.
Measured: Baseline, up to 28 days
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Change from baseline in SD of nocturnal blood glucose values at each time points was calculated.
Measured: Baseline, up to 28 days
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Measured: Up to 29 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Sep 201627 Apr 2017

First posted12 May 2016 (estimated)
Study start8 Sep 2016
Primary completion27 Apr 2017
Study completion27 Apr 2017

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.
Publications (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02771093
Sponsor's protocol ID: Trelagliptin-4001
Other IDs: U1111-1182-4062, JapicCTI-163250
Acronym: TRACK
Status last verified: Dec 2023
First submitted: 11 May 2016
Last updated: 12 Dec 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.
PubMed 31562608

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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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: An Exploratory Study to Evaluate the Effects of Trelagliptin and Alogliptin by CGM on Glucose Variability for One Week in Patients With Type 2 Diabetes Mellitus
ClinicalTrials.gov ID: NCT02771093
Acronym / sponsor ID: TRACK / Trelagliptin-4001
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2, Diabetes, Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: TakedaIndustry (pharma, biotech, devices)
Study start: 8 Sep 2016 (actual)
Primary completion: 27 Apr 2017 (actual)
Study completion: 27 Apr 2017 (actual)
First posted: 12 May 2016 (estimated)
Results: Posted 10 Dec 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Trelagliptin 100 mg group	Experimental	Drug: TrelagliptinTrelagliptin 100 mg once weekly taken orally before breakfast
Alogliptin 25 mg group	Experimental	Drug: AlogliptinAlogliptin 25 mg once daily taken orally before breakfast

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Participants who, in the opinion of the principal investigator or the investigator, are capable of understanding the content of the clinical research and complying with the research protocol requirements.
Participants who are able to sign and date the informed consent form and information sheet prior to the start of study procedures.
Participants diagnosed with type 2 diabetes mellitus.
Participants with a glycated hemoglobin (HbA1c) [National Glycohemoglobin Standardization Program (NGSP value)] value ≥ 6.5% and < 8.5% at the start of the observation period (Day -2).
Participants who experience a ≤ ±1.0% change in HbA1c (NGSP value) at the start of the observation period (Day -2) as compared with an HbA1c value obtained during the preceding 6 weeks.

Key exclusion criteria (18 listed)

Participants who received anti-diabetic medications within 4 weeks prior to the start of the observation period.
Participants who have changed (including discontinuation or interruption) HMG-CoA reductase inhibitors or received new HMG-CoA reductase inhibitors ≤ 4 weeks before the start of the observation period.
Participants with clinically evident hepatic dysfunction (e.g., aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2.5-fold the upper limit of normal at the start of the observation period [Day -2]).
Participants with moderate renal dysfunction, severe renal dysfunction or renal failure (e.g., creatinine clearance < 50 mL/min or serum creatinine > 1.4 mg/dL in men or > 1.2 mg/dL in women [equivalent to the creatinine clearance for persons aged 60 years with a body weight of 65 kg] at the start of the observation period [Day -2]).
Participants with severe heart disease, cerebrovascular disorder, or severe pancreatic, hematologic or other diseases.

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
TrelagliptinTrelagliptin 100 mg tablet	Drug	Trelagliptin 100 mg group
AlogliptinAlogliptin 25 mg tablet	Drug	Alogliptin 25 mg group

Primary outcome

Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values
Time frame: Baseline, up to 28 days
Changes in the SD of 24-hour blood glucose values (mg/dL) for each 7-day period between Week 3 and Week 4 (between Day 2 on Week 3 [Day 22] and Day 8 on Week 3 [Day 28]) of the treatment period, calculated from the value at the start of the observation period.

23 secondary outcomes

Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (180 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (110 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (140 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose When Specific Blood Glucose Levels (160 mg/dL) Are Observed During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 140 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 160 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in Time During Periods When Blood Glucose Levels Reached 180 mg/dL (Hyperglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels is Less Than 70 mg/dL (Hypoglycemia)
Time frame: Baseline, up to 28 days
Change From Baseline in Peak Postprandial Glucose Levels During the 3 Hour Time Period After Breakfast, Lunch and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in Maximum Variation of Blood Glucose Levels Between Before and After Breakfast, Lunch, and Evening Meal
Time frame: Baseline, up to 28 days
Change From Baseline in Mean Amplitude Glycemic Excursions (MAGE)
Time frame: Baseline, up to 28 days
Change From Baseline in Mean 24-hour Blood Glucose Levels
Time frame: Baseline, up to 28 days
Change From Baseline in Mean Daytime Blood Glucose Levels
Time frame: Baseline, up to 28 days
Change From Baseline in Mean Nocturnal Blood Glucose Levels
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose
Time frame: Baseline, up to 28 days
Change From Baseline in AUC for Blood Glucose During Periods When Blood Glucose Levels Reached 110 mg/dL (Hypoglycemia)
Time frame: Baseline, up to 28 days
Standard Deviation (SD) of 24-hour Blood Glucose Values
Time frame: Baseline, up to 28 days
Changes From Baseline in the SD of Daytime Blood Glucose Values
Time frame: Baseline, up to 28 days
Changes From Baseline in the SD of Nocturnal Blood Glucose Values
Time frame: Baseline, up to 28 days
Number of Participants Reporting One or More Treatment-emergent Adverse Events
Time frame: Up to 29 days

Results and safety

Results posted to the registry on 10 Dec 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Trelagliptin 100 mg	13	13
Alogliptin 25 mg	14	14

Primary outcome: Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values

Time frame: Baseline, up to 28 days. Mean (95% Confidence Interval). Unit: mg/dL

Measure	Trelagliptin 100 mg n = 13	Alogliptin 25 mg n = 14
Day(D) 2 Week(W) 3	-7.51 (-17.10 to 2.08)	-13.04 (-20.84 to -5.23)
D3W3	-11.76 (-21.12 to -2.40)	-15.24 (-21.87 to -8.61)
D4W3	-11.71 (-21.84 to -1.58)	-12.91 (-18.55 to -7.26)
D5W3	-9.89 (-19.83 to 0.05)	-13.28 (-21.28 to -5.27)
D6W3	-12.75 (-22.01 to -3.49)	-11.94 (-20.58 to -3.29)
D7W3	-9.50 (-18.58 to -0.42)	-10.90 (-20.00 to -1.80)
D8W3	-7.35 (-15.13 to 0.44)	-11.63 (-18.67 to -4.59)

Population analysed: Full analysis set (FAS); FAS was defined as participants who were randomized and received at least one dose of the study drug.

23 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 29 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Alogliptin 25 mg	0 of 13 (0%)	1 of 13 (7.7%)	0 of 13
Trelagliptin 100 mg	0 of 14 (0%)	2 of 14 (14.3%)	0 of 14

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.
Derived from this study: PubMed 31562608Nishimura R, Osonoi T, Koike Y, Miyata K, Shimasaki Y. A Randomized Pilot Study of the Effect of Trelagliptin and Alogliptin on Glycemic Variability in Patients with Type 2 Diabetes. Adv Ther. 2019 Nov;36(11):3096-3109. doi: 10.1007/s12325-019-01097-z. Epub 2019 Sep 27.

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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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Trelagliptin and Alogliptin in people with Type 2 Diabetes Mellitus, run by Takeda at 1 site 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 8 inclusion and 18 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 1 site 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 10 Dec 2018). 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?

Changes From Baseline in the Standard Deviation (SD) of 24-hour Blood Glucose Values (time frame: Baseline, up to 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02771093, which also lists 1 linked publication.

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.