NCT01318070

Brief Summary

The purpose of this study was to evaluate the efficacy and safety of alogliptin, once daily (QD) combined with a thiazolidine taken QD in type 2 diabetic patients with uncontrolled blood glucose.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
339

participants targeted

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

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
11 months 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
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 18, 2011

Completed
4 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

March 16, 2011

Results QC Date

June 8, 2011

Last Update Submit

February 1, 2012

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes Mellitus - Type2Diabetes 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 and glycosylated hemoglobin collected at baseline.

    Baseline and Week 12.

Secondary Outcomes (8)

  • 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.

  • +3 more secondary outcomes

Study Arms (3)

Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD

EXPERIMENTAL
Drug: Alogliptin and pioglitazone

Alogliptin 25 mg QD and Pioglitazone 15 or 30 mg QD

EXPERIMENTAL
Drug: Alogliptin and pioglitazone

Pioglitazone (15mg or 30mg ) QD

ACTIVE COMPARATOR
Drug: Pioglitazone

Interventions

Alogliptin and pioglitazoneDRUG

Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Also known as: Alogliptin (SYR-322), Pioglitazone: Actos®
Alogliptin 12.5 mg QD and Pioglitazone 15 or 30mg QD
PioglitazoneDRUG

Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.

Also known as: Pioglitazone: Actos®
Pioglitazone (15mg or 30mg ) QD

Eligibility Criteria

Age33 Years - 88 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Had been taking pioglitazone at a stable dose (15 mg/day or 30 mg/day) for at least 16 weeks prior to the start of the treatment period (Week 0).
  • Had glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 14 weeks after the start of the observation period (Week -2).
  • Had HbA1c difference within 10.0%\* at 10 weeks after the start of the observation period (Week -6) and 14 weeks after the start of the observation period (Week -2) from 10 weeks after the start of the observation period (Week -6) (\*rounded off to the first decimal place).
  • Was receiving specific diet and exercise (if any) therapies during the observation period.

You may not qualify if:

  • Had taken a diabetic medications other than pioglitazone within 16 weeks before the start of the treatment period (Week 0).
  • Had a history or symptoms of cardiac failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

alogliptinPioglitazone

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

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

Study Officials

  • Professor, Diabetes and Endocrine Division, 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

March 16, 2011

First Posted

March 18, 2011

Study Start

November 1, 2007

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

February 3, 2012

Results First Posted

July 6, 2011

Record last verified: 2012-02