NCT02512068 is a Phase 3 clinical trial of Trelagliptin 25 mg in Type 2 Diabetes Mellitus, sponsored by Takeda.

Who is sponsoring NCT02512068?

NCT02512068 is sponsored by Takeda.

What drugs are being tested in NCT02512068?

Interventions in NCT02512068: Trelagliptin 25 mg, Placebo.

What condition does NCT02512068 study?

NCT02512068 studies Type 2 Diabetes Mellitus.

Is NCT02512068 still recruiting?

NCT02512068 is currently completed. Last updated 12 December 2023.

Are results published for NCT02512068?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2023-12-12 · How we verify

NCT02512068

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 12 December 2023

What this trial tests

Phase 3 trial testing Trelagliptin 25 mg in Type 2 Diabetes Mellitus in 107 participants. Completed in 24 April 2018.

Timeline

7 August 2015

Primary endpoint
24 April 2018

24 April 2018

Quick facts

Lead sponsor	Takeda
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	107
Start date	7 August 2015
Primary completion	24 April 2018
Estimated completion	24 April 2018
Sites	49 locations across Japan

Drugs / interventions tested

Trelagliptin 25 mg — full drug profile →
Placebo

Conditions studied

Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →

Sponsor

Takeda — full company profile →

Who can join

20 and older, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in HbA1c at the End of Treatment Period I Primary · Baseline (Week 0) and end of Treatment Period I (Up to Week 12)

Group	Value	95% CI
Trelagliptin 25 mg	-0.71	± 0.087
Placebo and Trelagliptin 25 mg	0.01	± 0.089

Number of Participants Who Had One or More Treatment Emergent Adverse Event (TEAE) Before the Start of Study Drug Administration in Treatment Period II Primary · 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 ad

Group	Value	95% CI
Trelagliptin 25 mg	40
Placebo and Trelagliptin 25 mg	32

Number of Participants Who Had One or More TEAE Occurred After 1st Dose of Trelagliptin 25 mg Tablet Primary · 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 receivi

Group	Value	95% CI
Trelagliptin 25 mg	54
Placebo and Trelagliptin 25 mg	48

Changes From Baseline in HbA1c Secondary · 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)

Reported data was the change from baseline in HbA1c at each time point.

At Week 2

Group	Value	95% CI
Trelagliptin 25 mg	-0.24	± 0.274
Placebo and Trelagliptin 25 mg	0.05	± 0.260

At Week 4

Group	Value	95% CI
Trelagliptin 25 mg	-0.46	± 0.370
Placebo and Trelagliptin 25 mg	0.02	± 0.362

At Week 8

Group	Value	95% CI
Trelagliptin 25 mg	-0.64	± 0.556
Placebo and Trelagliptin 25 mg	-0.05	± 0.530

At Week 12

Group	Value	95% CI
Trelagliptin 25 mg	-0.73	± 0.576
Placebo and Trelagliptin 25 mg	0.03	± 0.740

At the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	-0.70	± 0.555
Placebo and Trelagliptin 25 mg	0.00	± 0.731

At the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	-0.76	± 0.824
Placebo and Trelagliptin 25 mg	-0.74	± 0.843

Number of Participants Achieving <6.0%, <7.0%, and <8.0% HbA1c at the End of Treatment Period I and Period II Secondary · At the end of Treatment Period I (Up to Week 12) and Period II (Up to Week 52)

HbA1c <6.0% at the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	3
Placebo and Trelagliptin 25 mg	2

HbA1c <6.0% at the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	7
Placebo and Trelagliptin 25 mg	8

HbA1c <7.0% at the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	22
Placebo and Trelagliptin 25 mg	7

HbA1c <7.0% at the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	22
Placebo and Trelagliptin 25 mg	18

HbA1c <8.0% at the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	10
Placebo and Trelagliptin 25 mg	5

HbA1c <8.0% at the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	11
Placebo and Trelagliptin 25 mg	8

Change From Baseline in Fasting Plasma Glucose Secondary · 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)

Reported data was the change from baseline in fasting plasma glucose at each time point.

At Week 2

Group	Value	95% CI
Trelagliptin 25 mg	-12.9	± 22.67
Placebo and Trelagliptin 25 mg	2.3	± 20.78

At Week 4

Group	Value	95% CI
Trelagliptin 25 mg	-11.3	± 31.25
Placebo and Trelagliptin 25 mg	-2.6	± 32.49

At Week 8

Group	Value	95% CI
Trelagliptin 25 mg	-12.7	± 25.56
Placebo and Trelagliptin 25 mg	-4.3	± 27.28

At Week 12

Group	Value	95% CI
Trelagliptin 25 mg	-15.9	± 31.95
Placebo and Trelagliptin 25 mg	-0.3	± 24.86

At the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	-14.8	± 31.51
Placebo and Trelagliptin 25 mg	0.8	± 25.50

At the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	-14.3	± 37.48
Placebo and Trelagliptin 25 mg	-7.3	± 34.31

Change From Baseline in Glycoalbumin Secondary · 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)

Reported data was the change from baseline in glycoalbumin at each time point.

At Week 2

Group	Value	95% CI
Trelagliptin 25 mg	-1.67	± 1.137
Placebo and Trelagliptin 25 mg	0.10	± 1.059

At Week 4

Group	Value	95% CI
Trelagliptin 25 mg	-2.46	± 1.534
Placebo and Trelagliptin 25 mg	-0.01	± 1.474

At Week 8

Group	Value	95% CI
Trelagliptin 25 mg	-2.69	± 2.038
Placebo and Trelagliptin 25 mg	-0.21	± 2.033

At Week 12

Group	Value	95% CI
Trelagliptin 25 mg	-2.85	± 2.523
Placebo and Trelagliptin 25 mg	-0.27	± 2.563

At the End of Treatment Period I

Group	Value	95% CI
Trelagliptin 25 mg	-2.81	± 2.401
Placebo and Trelagliptin 25 mg	-0.15	± 2.537

At the End of Treatment Period II

Group	Value	95% CI
Trelagliptin 25 mg	-3.12	± 2.580
Placebo and Trelagliptin 25 mg	-3.06	± 2.604

Numbers of Participants With TEAE Related to Vital Signs Before the Start of Study Drug Administration in Treatment Period II Secondary · Up to Week 12

Number of participants with a vital sign-related TEAE classified under the System Organ Class of "investigations," was reported.

Group	Value	95% CI
Trelagliptin 25 mg	1
Placebo and Trelagliptin 25 mg	2

Number of Participants With Markedly Abnormal Values of 12-Lead Electrocardiogram (ECG) Parameters Before the Start of Study Drug Administration in Treatment Period II Secondary · Up to Week 12

Here "QTcF" is corrected QT interval by Fridericia formula.

QTcF Interval >450 millisecond (msec)

Group	Value	95% CI
Trelagliptin 25 mg	13
Placebo and Trelagliptin 25 mg	16

QTcF Interval >480 msec

Group	Value	95% CI
Trelagliptin 25 mg	3
Placebo and Trelagliptin 25 mg	5

QTcF Interval >500 msec

Group	Value	95% CI
Trelagliptin 25 mg	1
Placebo and Trelagliptin 25 mg	1

Number of Participants With Markedly Abnormal Values of Clinical Laboratory Parameters Before the Start of Study Drug Administration in Treatment Period II Secondary · Up to Week 12

Here "U/L" is Unit/Litter, and "ULN" is Upper Limit of Normal.

Amylase (U/L) >2×ULN

Group	Value	95% CI
Trelagliptin 25 mg	4
Placebo and Trelagliptin 25 mg	1

Lipase (U/L) >3×ULN

Group	Value	95% CI
Trelagliptin 25 mg	1
Placebo and Trelagliptin 25 mg	3

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to Week 54. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Trelagliptin 25 mg

Serious: 23/55 (42%)

Deaths: 0/55

Placebo and Trelagliptin 25 mg

Serious: 16/48 (33%)

Deaths: 0/48

Serious adverse events (43 terms)

Reaction	System	Trelagliptin 25 mg	Placebo and Trelagliptin 2…
Cataract	Eye disorders	—	—
Diabetic retinopathy	Eye disorders	—	—
Fall	Injury, poisoning and procedural complications	—	—
Shunt occlusion	Injury, poisoning and procedural complications	—	—
Chronic kidney disease	Renal and urinary disorders	—	—
Angina pectoris	Cardiac disorders	—	—
Acute coronary syndrome	Cardiac disorders	—	—
Acute myocardial infarction	Cardiac disorders	—	—
Atrioventricular block complete	Cardiac disorders	—	—
Coronary artery occlusion	Cardiac disorders	—	—
Coronary artery stenosis	Cardiac disorders	—	—
Sudden hearing loss	Ear and labyrinth disorders	—	—
Gastrointestinal necrosis	Gastrointestinal disorders	—	—
Gastrooesophageal reflux disease	Gastrointestinal disorders	—	—
Large intestine polyp	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Oedema peripheral	General disorders	—	—
Vascular stent stenosis	General disorders	—	—
Cholangitis acute	Hepatobiliary disorders	—	—
Cholecystitis	Hepatobiliary disorders	—	—
Anaphylactic shock	Immune system disorders	—	—
Pneumonia	Infections and infestations	—	—
Cholangitis infective	Infections and infestations	—	—
Diverticulitis	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—

Other adverse events (24 terms — click to expand)

Reaction	System	Trelagliptin 25 mg	Placebo and Trelagliptin 2…
Nasopharyngitis	Infections and infestations	—	—
Fall	Injury, poisoning and procedural complications	—	—
Hypoglycaemia	Metabolism and nutrition disorders	—	—
Contusion	Injury, poisoning and procedural complications	—	—
Diarrhoea	Gastrointestinal disorders	—	—
Vomiting	Gastrointestinal disorders	—	—
Constipation	Gastrointestinal disorders	—	—
Hyperkalaemia	Metabolism and nutrition disorders	—	—
Insomnia	Psychiatric disorders	—	—
Hypertension	Vascular disorders	—	—
Influenza	Infections and infestations	—	—
Blood pressure decreased	Investigations	—	—
Headache	Nervous system disorders	—	—
Dizziness	Nervous system disorders	—	—
Dental caries	Gastrointestinal disorders	—	—
Haemorrhoids	Gastrointestinal disorders	—	—
Procedural hypotension	Injury, poisoning and procedural complications	—	—
Shunt stenosis	Injury, poisoning and procedural complications	—	—
Skin abrasion	Injury, poisoning and procedural complications	—	—
Back pain	Musculoskeletal and connective tissue disorders	—	—
Myalgia	Musculoskeletal and connective tissue disorders	—	—
Upper respiratory tract inflammation	Respiratory, thoracic and mediastinal disorders	—	—
Eczema	Skin and subcutaneous tissue disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—

Most-reported serious reactions: Cataract, Diabetic retinopathy, Fall, Shunt occlusion, Chronic kidney disease, Angina pectoris, Acute coronary syndrome, Acute myocardial infarction.

Data from ClinicalTrials.gov NCT02512068 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Efficacy and safety of trelagliptin in Japanese patients with type 2 diabetes with severe renal impairment or end-stage renal disease: Results from a randomized, phase 3 study.
Kaku K, Ishida K, Shimizu K, Achira M, et al · · 2020 · cited 6× · PMID 31389201 · DOI 10.1111/jdi.13126

Verify or expand the search:

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Other Takeda trials

Trials by the same sponsor.

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NCT07403968 — A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease · Phase 2 · not yet recruiting
NCT07293364 — A Study to Learn About the C1-Inhibitor Function as Diagnosis for Hereditary Angioedema · NA · not yet recruiting
NCT07218393 — A Study About the Diagnosis and Management of Hereditary Angioedema (HAE) in Egypt · not yet recruiting
NCT07445087 — A Study of Takhzyro in Teenagers and Adults With Hereditary Angioedema (HAE) in South Korea · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02512068 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Takeda
Last refreshed: 12 December 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02512068.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02512068

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (43 terms)

Sponsor's own description

Publications & conference data

Related trials

Other recruiting trials for Type 2 Diabetes Mellitus

Other Takeda trials

Verify against primary sources