Study of Combination Therapy With SYR-322

NCT ID: NCT01521962

Last Updated: 2013-11-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

67 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study Groups

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SYR-322 (Alogliptin) QD

SYR-322 25 mg, orally.

Group Type EXPERIMENTAL

Alogliptin

Intervention Type DRUG

Alogliptin tablets

Insulin

injection

Group Type PLACEBO_COMPARATOR

Insulin

Intervention Type DRUG

Insulin injection

Interventions

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Alogliptin

Alogliptin tablets

Intervention Type DRUG

Insulin

Insulin injection

Intervention Type DRUG

Other Intervention Names

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SYR-322

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Senior Manager

Role: STUDY_DIRECTOR

Takeda

Locations

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Aomori, Aomori, Japan

Site Status

Hirosaki-shi, Aomori, Japan

Site Status

Kashiwa-shi, Chiba, Japan

Site Status

Kisarazu-shi, Chiba, Japan

Site Status

Kitakyushu-shi, Fukuoka, Japan

Site Status

Aki-gun, Hiroshima, Japan

Site Status

Fukuyama-shi, Hiroshima, Japan

Site Status

Nishinomiya-shi, Hyōgo, Japan

Site Status

Koga-shi, Ibaraki, Japan

Site Status

Ushiku-shi, Ibaraki, Japan

Site Status

Kahoku-gun, Ishikawa-ken, Japan

Site Status

Hanamaki-shi, Iwate, Japan

Site Status

Morioka, Iwate, Japan

Site Status

Kagoshima, Kagoshima-ken, Japan

Site Status

Satsuma-sendai-shi, Kagoshima-ken, Japan

Site Status

Kumamoto, Kumamoto, Japan

Site Status

Minamata-shi, Kumamoto, Japan

Site Status

Miyazaki, Miyazaki, Japan

Site Status

Nigata-shi, Niigata, Japan

Site Status

Hirakata-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Osaka-sayama-shi, Osaka, Japan

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Takatsuki-shi, Osaka, Japan

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Yao-shi, Osaka, Japan

Site Status

Kuki-shi, Saitama, Japan

Site Status

Ōtsu, Shiga, Japan

Site Status

Hamamatsu, Shizuoka, Japan

Site Status

Shizuoka, Shizuoka, Japan

Site Status

Shimotsuke-shi, Tochigi, Japan

Site Status

Shinagawa-ku, Tokyo, Japan

Site Status

Toyama, Toyama, Japan

Site Status

Sagae-shi, Yamagata, Japan

Site Status

Yamagata, Yamagata, Japan

Site Status

Countries

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Japan

References

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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.

Reference Type DERIVED
PMID: 25190226 (View on PubMed)

Other Identifiers

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U1111-1127-1525

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-121736

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322/CCT-901

Identifier Type: -

Identifier Source: org_study_id