NCT01521962

Brief Summary

To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at below P25 for phase_3 diabetes-mellitus

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3 diabetes-mellitus

Geographic Reach
1 country

33 active sites

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

First Submitted

Initial submission to the registry

January 26, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 31, 2012

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 13, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

January 26, 2012

Last Update Submit

November 12, 2013

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value)

    Baseline and Week 12

Study Arms (2)

SYR-322 (Alogliptin) QD

EXPERIMENTAL

SYR-322 25 mg, orally.

Drug: Alogliptin

Insulin

PLACEBO COMPARATOR

injection

Drug: Insulin

Interventions

AlogliptinDRUG

Alogliptin tablets

Also known as: SYR-322
SYR-322 (Alogliptin) QD
InsulinDRUG

Insulin injection

Insulin

Eligibility Criteria

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

You may qualify if:

  • The subject is an outpatient.
  • The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

You may not qualify if:

  • The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  • The subject is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (33)

Unknown Facility

Aomori, Aomori, Japan

Location

Unknown Facility

Hirosaki-shi, Aomori, Japan

Location

Unknown Facility

Kashiwa-shi, Chiba, Japan

Location

Unknown Facility

Kisarazu-shi, Chiba, Japan

Location

Unknown Facility

Kitakyushu-shi, Fukuoka, Japan

Location

Unknown Facility

Aki-gun, Hiroshima, Japan

Location

Unknown Facility

Fukuyama-shi, Hiroshima, Japan

Location

Unknown Facility

Nishinomiya-shi, Hyōgo, Japan

Location

Unknown Facility

Koga-shi, Ibaraki, Japan

Location

Unknown Facility

Ushiku-shi, Ibaraki, Japan

Location

Unknown Facility

Kahoku-gun, Ishikawa-ken, Japan

Location

Unknown Facility

Hanamaki-shi, Iwate, Japan

Location

Unknown Facility

Morioka, Iwate, Japan

Location

Unknown Facility

Kagoshima, Kagoshima-ken, Japan

Location

Unknown Facility

Satsuma-sendai-shi, Kagoshima-ken, Japan

Location

Unknown Facility

Kumamoto, Kumamoto, Japan

Location

Unknown Facility

Minamata-shi, Kumamoto, Japan

Location

Unknown Facility

Miyazaki, Miyazaki, Japan

Location

Unknown Facility

Nigata-shi, Niigata, Japan

Location

Unknown Facility

Hirakata-shi, Osaka, Japan

Location

Unknown Facility

Osaka, Osaka, Japan

Location

Unknown Facility

Osaka-sayama-shi, Osaka, Japan

Location

Unknown Facility

Takatsuki-shi, Osaka, Japan

Location

Unknown Facility

Yao-shi, Osaka, Japan

Location

Unknown Facility

Kuki-shi, Saitama, Japan

Location

Unknown Facility

Ōtsu, Shiga, Japan

Location

Unknown Facility

Hamamatsu, Shizuoka, Japan

Location

Unknown Facility

Shizuoka, Shizuoka, Japan

Location

Unknown Facility

Shimotsuke-shi, Tochigi, Japan

Location

Unknown Facility

Shinagawa-ku, Tokyo, Japan

Location

Unknown Facility

Toyama, Toyama, Japan

Location

Unknown Facility

Sagae-shi, Yamagata, Japan

Location

Unknown Facility

Yamagata, Yamagata, Japan

Location

Related Publications (1)

  • Kaku K, Mori M, Kanoo T, Katou M, Seino Y. Efficacy and safety of alogliptin added to insulin in Japanese patients with type 2 diabetes: a randomized, double-blind, 12-week, placebo-controlled trial followed by an open-label, long-term extension phase. Expert Opin Pharmacother. 2014 Oct;15(15):2121-30. doi: 10.1517/14656566.2014.956722. Epub 2014 Sep 5.

    PMID: 25190226DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

alogliptinInsulin

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ProinsulinInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Senior Manager

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2012

First Posted

January 31, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 13, 2013

Record last verified: 2013-11

Locations

JP(33)