NCT01263483 is a Phase 2/Phase 3 clinical trial of Alogliptin and voglibose in Type 2 Diabetes Mellitus, sponsored by Takeda.

Who is sponsoring NCT01263483?

NCT01263483 is sponsored by Takeda.

What drugs are being tested in NCT01263483?

Interventions in NCT01263483: Alogliptin and voglibose, Alogliptin and voglibose, Voglibose.

What condition does NCT01263483 study?

NCT01263483 studies Type 2 Diabetes Mellitus.

Is NCT01263483 still recruiting?

NCT01263483 is currently completed. Last updated 1 February 2012.

Are results published for NCT01263483?

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

Last reviewed 2012-02-01 · How we verify

NCT01263483

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

A Phase 2/3, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With α-glucosidase Inhibitor in Subjects With Type 2 Diabetes in Japan

Completed Phase 2/Phase 3 Results posted Last updated 1 February 2012

What this trial tests

Phase 2/Phase 3 trial testing Alogliptin and voglibose in Type 2 Diabetes Mellitus in 230 participants. Completed in 1 April 2008.

Timeline

1 January 2007

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	Takeda
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	230
Start date	1 January 2007
Primary completion	1 April 2008
Estimated completion	1 April 2008

Drugs / interventions tested

Alogliptin and voglibose — full drug profile →
Alogliptin and voglibose — full drug profile →
Voglibose (VOGLIBOSE) — full drug profile →

Conditions studied

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

Sponsor

Takeda — full company profile →

Who can join

Adults 33 to 85, any sex, with Type 2 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Change From Baseline in Glycosylated Hemoglobin (Week 12).
Time frame: Baseline and Week 12.
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at week 12 or final visit and glycosylated hemoglobin collected at baseline.

Sponsor's own description

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an α-glucosidase inhibitor taken three times daily (TID) in type 2 diabetic patients with uncontrolled blood glucose.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Dipeptidyl peptidase-4 inhibitors and risk of heart failure in type 2 diabetes: systematic review and meta-analysis of randomised and observational studies.
Li L, Li S, Deng K, Liu J, et al · · 2016 · cited 157× · PMID 26888822 · DOI 10.1136/bmj.i610
Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension.
Seino Y, Fujita T, Hiroi S, Hirayama M, et al · · 2011 · cited 42× · PMID 22106975 · DOI 10.1185/03007995.2011.614936

Verify or expand the search:

Other recruiting trials for Type 2 Diabetes Mellitus

Currently open trials in the same condition.

NCT07351058 — A Clinical Study to Evaluate the Effects of RO7795068 in Participants With Obesity or Overweight and Type 2 Diabetes · Phase 3 · recruiting
NCT07373938 — Carotid Wall Texture as a Cardiovascular Risk Biomarker in Type 2 Diabetes Mellitus · recruiting
NCT07433062 — A Study to Evaluate the Effect of AZD6793 on the Pharmacokinetics and Pharmacodynamics of Metformin in Participants With · Phase 1 · recruiting
NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
NCT07232537 — An Observational Study Called FINE-REAL Korea to Learn More About the Use of the Drug Finerenone in People With Chronic · recruiting

Other Takeda trials

Trials by the same sponsor.

NCT05669729 — A Survey to Assess Participants', Caregivers', and Nurses' Use and Understanding of Educational Material on Velagluceras · not yet recruiting
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 NCT01263483 (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: 1 February 2012

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/NCT01263483.

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