NCT01318109

Brief Summary

The purpose of this study was evaluate the efficacy and safety of alogliptin, once dairy (QD) combined with metformin taken twice daily (BID) or three times daily (TID) 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
288

participants targeted

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

Timeline
Completed

Started Aug 2008

Shorter than P25 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

August 1, 2008

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
2 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 11, 2011

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

8 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 - 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 (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 metformin 500mg BID or 750mg TID

ACTIVE COMPARATOR
Drug: Alogliptin and metformin

Alogliptin 25mg QD and metformin 500mg BID or 750mg TID

ACTIVE COMPARATOR
Drug: Alogliptin and metformin

Metformin 500mg BID or 750mg TID

ACTIVE COMPARATOR
Drug: Metformin

Interventions

Alogliptin and metforminDRUG

Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.

Also known as: SYR-32, Glycoran
Alogliptin 12.5 mg QD and metformin 500mg BID or 750mg TID
MetforminDRUG

Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.

Also known as: Glycoran
Metformin 500mg BID or 750mg TID

Eligibility Criteria

Age26 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Had been taking metformin at a stable dose regimen (500 mg/day twice daily after meal or 750 mg/day three times daily after meal) for at least 12 weeks prior to the initiation of the treatment period (Week 0).
  • Had an glycosylated hemoglobin (HbA1c) of 6.5% or more and below 10.0% at 8 weeks after the initiation of the observation period (Week -4).
  • Had an HbA1c difference between 4 weeks after the initiation of the observation period (Week -8) and 8 weeks after the initiation of the observation period (Week -4) being within 10.0%\* of the value at 4 weeks after the initiation of the observation period (Week -8) (\*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 other diabetic medications than metformin within 12 weeks before the initiation of the treatment period (Week 0).
  • With a history or symptoms of lactic acidosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

alogliptinMetformin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

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

August 1, 2008

Primary Completion

April 1, 2009

Study Completion

April 1, 2009

Last Updated

February 3, 2012

Results First Posted

July 11, 2011

Record last verified: 2012-02