Open-label Study of TAK-875
This study has been completed.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01433419
First received: September 12, 2011
Last updated: March 21, 2013
Last verified: March 2013
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Purpose
The purpose of this study is to evaluate the safety and efficacy of treatment with TAK-875 in diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: TAK-875 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Parallel Assignment |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- Adverse events [ Designated as safety issue: Yes ]
| Enrollment: | 333 |
| Study Start Date: | January 2012 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: TAK-875 25 mg | Drug: TAK-875 |
| Experimental: TAK-875 50 mg | Drug: TAK-875 |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- The participant is an outpatient.
- The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria:
- The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The participant is considered ineligible for the study for any other reason by the investigator or sub-investigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433419
Locations
| Japan | |
| Katori-shi, Chiba, Japan | |
| Niihama-shi, Ehime, Japan | |
| Chikushino-shi, Fukuoka, Japan | |
| Fukuoka-shi, Fukuoka, Japan | |
| Onga-gun, Fukuoka, Japan | |
| Yukuhashi-shi, Fukuoka, Japan | |
| Hiroshima-shi, Hiroshima, Japan | |
| Chitose-shi, Hokkaido, Japan | |
| Sapporo-shi, Hokkaido, Japan | |
| Koga-shi, Ibaragi, Japan | |
| Ushiku-shi, Ibaragi, Japan | |
| Chigasaki-shi, Kanagawa, Japan | |
| Kamakura-shi, Kanagawa, Japan | |
| Minamata-shi, Kumamoto, Japan | |
| Yatsushiro-shi, Kumamoto, Japan | |
| Sasebo-shi, Nagasaki, Japan | |
| Kashihara-shi, Nara, Japan | |
| Okinawa-shi, Okinawa, Japan | |
| Izumi-shi, Osaka, Japan | |
| Suita-shi, Osaka, Japan | |
| Fujimi-shi, Saitama, Japan | |
| Shimotsuga-gun, Tochigi, Japan | |
| Komatsushima-shi, Tokushima, Japan | |
| Bunkyo-ku, Tokyo, Japan | |
| Chiyoda-ku, Tokyo, Japan | |
| Mitaka-shi, Tokyo, Japan | |
| Shibuya-ku, Tokyo, Japan | |
| Shinjuku-ku, Tokyo, Japan | |
| Toshima-ku, Tokyo, Japan | |
| Shunan-shi, Yamaguchi, Japan | |
| Ube-shi, Yamaguchi, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
More Information
No publications provided
| Responsible Party: | Takeda ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01433419 History of Changes |
| Other Study ID Numbers: | TAK-875/OCT-003, U1111-1124-1619, JapicCTI-111605 |
| Study First Received: | September 12, 2011 |
| Last Updated: | March 21, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Takeda:
|
Drug Therapy |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on June 18, 2013