A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

NCT ID: NCT01686711

Last Updated: 2023-08-31

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

PHASE4

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-12-31

Brief Summary

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To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Study Groups

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SYR-322 25 mg , AD-4833 15 mg

Group Type EXPERIMENTAL

AD-4833 15 mg

Intervention Type DRUG

SYR-322 25 mg , AD-4833 30 mg

Group Type EXPERIMENTAL

AD-4833 30 mg

Intervention Type DRUG

SYR-322 25 mg , AD-4833 placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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AD-4833 15 mg

Intervention Type DRUG

AD-4833 30 mg

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Those judged to be capable of understanding and complying with protocol requirements by the investigator or subinvestigator.
* Those who can sign and date a written, informed consent form prior to the initiation of any study procedures.

Exclusion Criteria

* Those with concurrent serious cardiac disease, serious cerebrovascular disorder, or serious pancreatic or hematological disease etc.
* Others who are assessed to be ineligible for the study 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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Study Director

Role: STUDY_DIRECTOR

Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)

Locations

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Hirosaki-shi, Aomori, Japan

Site Status

Kisaratsu-shi, Chiba, Japan

Site Status

Matsuyama, Ehime, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Kitakyushu-shi, Fukuoka, Japan

Site Status

Kurume-shi, Fukuoka, Japan

Site Status

Fukuyama-shi, Hiroshima, Japan

Site Status

Hiroshima, Hiroshima, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Koga-shi, Ibaraki, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Kumamoto, Kumamoto, Japan

Site Status

Miyazaki, Miyazaki, Japan

Site Status

Suita-shi, Osaka, Japan

Site Status

Koshigaya-shi, Saitama, Japan

Site Status

Ōtsu, Shiga, Japan

Site Status

Chiyoda-ku, Tokyo, Japan

Site Status

Chuo-ku, Tokyo, Japan

Site Status

Itabashi-ku, Tokyo, Japan

Site Status

Meguro-ku, Tokyo, Japan

Site Status

Minato-ku, Tokyo, Japan

Site Status

Ohta-ku, Tokyo, Japan

Site Status

Shinjuku-ku, Tokyo, Japan

Site Status

Toyama, Toyama, Japan

Site Status

Shimonoseki-shi, Yamaguchi, Japan

Site Status

Countries

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Japan

Other Identifiers

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U1111-1132-3209

Identifier Type: REGISTRY

Identifier Source: secondary_id

JapicCTI-121916

Identifier Type: REGISTRY

Identifier Source: secondary_id

SYR-322-4833/CCT-901

Identifier Type: -

Identifier Source: org_study_id

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