NCT01263509

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
179

participants targeted

Target at P50-P75 for phase_2 type-2-diabetes-mellitus

Timeline
Completed

Started Jun 2007

Typical duration for phase_2 type-2-diabetes-mellitus

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2010

Completed
8 months until next milestone

Results Posted

Study results publicly available

August 29, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

1.3 years

First QC Date

December 17, 2010

Results QC Date

June 8, 2011

Last Update Submit

February 1, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus - Type 2Diabetes MellitusDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Adverse Events.

    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 data with onset occurring more than 30 days after last dose of study drug (AE start date - last dose date \>30) will be listed, but not included in the summary tables below.

    52 Weeks.

Secondary Outcomes (59)

  • Change From Baseline in Glycosylated Hemoglobin (Week 8).

    Baseline and Week 8.

  • Change From Baseline in Glycosylated Hemoglobin (Week 12).

    Baseline and Week 12.

  • Change From Baseline in Glycosylated Hemoglobin (Week 16).

    Baseline and Week 16.

  • Change From Baseline in Glycosylated Hemoglobin (Week 20).

    Baseline and Week 20.

  • Change From Baseline in Glycosylated Hemoglobin (Week 24).

    Baseline and Week 24.

  • +54 more secondary outcomes

Study Arms (2)

Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID

EXPERIMENTAL
Drug: Alogliptin and voglibose

Alogliptin 25 mg QD and Voglibose 0.2 mg TID

EXPERIMENTAL
Drug: Alogliptin and voglibose

Interventions

Alogliptin and vogliboseDRUG

Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.

Also known as: SYR-322, Voglibose, BASEN®
Alogliptin 12.5 mg QD and Voglibose 0.2 mg TID

Eligibility Criteria

Age33 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had completed the phase 2 dose-ranging study (i.e., the subject had completed the study visit at Week 12).

You may not qualify if:

  • Had clinical manifestations of hepatic impairment (e.g., an aspartate aminotransferase or alanine aminotransferase value 2.5 times or more of the upper reference limit at Week 8 of treatment in the phase 2 dose-ranging study).
  • Had clinical manifestations of renal impairment (e.g., a creatinine value of 2 mg/dL or more at Week 8 of treatment in the phase 2 dose-ranging study).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Seino Y, Fujita T, Hiroi S, Hirayama M, Kaku K. Alogliptin plus voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind, placebo-controlled trial with an open-label, long-term extension. Curr Med Res Opin. 2011 Nov;27 Suppl 3:21-9. doi: 10.1185/03007995.2011.614936.

    PMID: 22106975DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

alogliptinvoglibose

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Results Point of Contact

Title
General Manager
Organization
Japan Development Center, Pharmaceutical Development Division
clinicaltrialregistry@tpna.com
+81-6-6204-5257

Study Officials

  • Professor, Department of Medicine

    Kawasaki Medical School

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2010

First Posted

December 20, 2010

Study Start

June 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 3, 2012

Results First Posted

August 29, 2011

Record last verified: 2012-02