NCT01263470

Brief Summary

The purpose of this study was to evaluate the dose-response relationships of alogliptin, once daily (QD) to an α-glucosidase inhibitor, three times daily (TID), to determine the optimal clinical dose for type 2 diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
480

participants targeted

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

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

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

January 1, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
3 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
7 months until next milestone

Results Posted

Study results publicly available

July 6, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

11 months

First QC Date

December 17, 2010

Results QC Date

June 8, 2011

Last Update Submit

February 1, 2012

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetes Mellitus - Type 2Diabetes MellitusDrug Therapy

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in Glycosylated Hemoglobin (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.

    Baseline and Week 12.

Secondary Outcomes (16)

  • Change From Baseline in Glycosylated Hemoglobin (Week 2).

    Baseline and Week 2.

  • Change From Baseline in Glycosylated Hemoglobin (Week 4).

    Baseline and Week 4.

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

    Baseline and Week 8.

  • Change From Baseline in Fasting Plasma Glucose (Week 2).

    Baseline and Week 2

  • Change From Baseline in Fasting Plasma Glucose (Week 4).

    Baseline and Week 4.

  • +11 more secondary outcomes

Study Arms (6)

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Alogliptin 6.25 mg QD

EXPERIMENTAL
Drug: Alogliptin

Alogliptin 12.5 mg QD

EXPERIMENTAL
Drug: Alogliptin

Alogliptin 25 mg QD

EXPERIMENTAL
Drug: Alogliptin

Alogliptin 50 mg QD

EXPERIMENTAL
Drug: Alogliptin

Voglibose 0.2 mg TID

ACTIVE COMPARATOR
Drug: Voglibose

Interventions

AlogliptinDRUG

Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks

Also known as: SYR-322
Alogliptin 6.25 mg QD
VogliboseDRUG

Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.

Also known as: Voglib, BASEN®
Voglibose 0.2 mg TID
PlaceboDRUG

Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.

Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A glycosylated hemoglobin (HbA1c) value of 6.5% or more and below 10.0% 4 weeks after the start of screening(Week -4).
  • A HbA1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
  • Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).

You may not qualify if:

  • Received any antidiabetic drug within the last 4 weeks before the start of screening (Week -8) or during screening.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Okayama, 701-0192, Japan

Location

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
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
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

January 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

February 3, 2012

Results First Posted

July 6, 2011

Record last verified: 2012-02

Locations

JP(1)