NCT01263509

A Long-term, Open-label Extension Study to Investigate the Long-term 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 179 participants. Completed in 1 October 2008.

Timeline

1 June 2007

Primary endpoint
1 October 2008

1 October 2008

Quick facts

Lead sponsor	Takeda
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	179
Start date	1 June 2007
Primary completion	1 October 2008
Estimated completion	1 October 2008

Drugs / interventions tested

• Alogliptin and voglibose — full drug profile →
• Alogliptin and 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.

• Number of Participants With Adverse Events.
  Time frame: 52 Weeks.
  A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing. Adverse events

Sponsor's own description

The purpose of this study was to evaluate the long-term safety and efficacy of alogliptin and an α-glucosidase inhibitor administered once daily (QD) or three times daily (TID) for 40 consecutive weeks in participants who completed a phase 2/3 α-glucosidase inhibitor add on study.

Publications & conference data

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

1. 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