Long-term Study of SYR-472
This study is currently recruiting participants.
Verified January 2013 by Takeda
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01431807
First received: September 8, 2011
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: SYR-472 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies |
Resource links provided by NLM:
Further study details as provided by Takeda:
Primary Outcome Measures:
- Adverse events [ Time Frame: 52 weeks. ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 622 |
| Study Start Date: | September 2011 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SYR-472 group
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
|
Drug: SYR-472
oral, for up to 52 weeks.
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
- Diabetes Mellitus
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 subinvestigator.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01431807
Contacts
| Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Locations
| Japan | |
| Recruiting | |
| Akita-shi, Akita, Japan | |
| Recruiting | |
| Kisarazu-shi, Chiba, Japan | |
| Recruiting | |
| Fukuoka-shi, Fukuoka, Japan | |
| Recruiting | |
| Munakata-shi, Fukuoka, Japan | |
| Active, not recruiting | |
| Koriyama-shi, Fukushima, Japan | |
| Recruiting | |
| Gihu-shi, Gihu, Japan | |
| Recruiting | |
| Fukuyama-shi, Hiroshima, Japan | |
| Recruiting | |
| Hiroshima-shi, Hiroshima, Japan | |
| Recruiting | |
| Eniwa-shi, Hokkaido, Japan | |
| Recruiting | |
| Ishikari-shi, Hokkaido, Japan | |
| Recruiting | |
| Nakagawa-gun, Hokkaido, Japan | |
| Recruiting | |
| Obihiro-shi, Hokkaido, Japan | |
| Recruiting | |
| Sapporo-shi, Hokkaido, Japan | |
| Recruiting | |
| Kobe-shi, Hyogo, Japan | |
| Recruiting | |
| Mito-shi, Ibaragi, Japan | |
| Active, not recruiting | |
| Naka-shi, Ibaragi, Japan | |
| Recruiting | |
| Takamatsu-shi, Kagawa, Japan | |
| Recruiting | |
| Sagamihara-shi, Kanagawa, Japan | |
| Recruiting | |
| Yokohama-shi, Kanagawa, Japan | |
| Recruiting | |
| Kumamoto-shi, Kumamoto, Japan | |
| Recruiting | |
| Tamana-shi, Kumamoto, Japan | |
| Recruiting | |
| Kyoto-shi, Kyoto, Japan | |
| Recruiting | |
| Nagano-shi, Nagano, Japan | |
| Recruiting | |
| Nagawaki-shi, Nagasaki, Japan | |
| Active, not recruiting | |
| Oita-shi, Oita, Japan | |
| Recruiting | |
| Mino-shi, Osaka, Japan | |
| Recruiting | |
| Osaka-shi, Osaka, Japan | |
| Recruiting | |
| Sakai-shi, Osaka, Japan | |
| Recruiting | |
| Ageo-shi, Saitama, Japan | |
| Recruiting | |
| Kawaguchi-shi, Saitama, Japan | |
| Recruiting | |
| Koshigaya-shi, Saitama, Japan | |
| Recruiting | |
| Kuki-shi, Saitama, Japan | |
| Recruiting | |
| Saitama-shi, Saitama, Japan | |
| Recruiting | |
| Suntou-gun, Shizuoka, Japan | |
| Active, not recruiting | |
| Oyama-shi, Tochigi, Japan | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan | |
| Recruiting | |
| Koganei-shi, Tokyo, Japan | |
| Recruiting | |
| Meguro-ku, Tokyo, Japan | |
| Recruiting | |
| Shibuya-ku, Tokyo, Japan | |
| Recruiting | |
| Tama-shi, Tokyo, Japan | |
| Recruiting | |
| Tiyoda-ku, Tokyo, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | Senior Director | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01431807 History of Changes |
| Other Study ID Numbers: | SYR-472/OCT-001, JapicCTI-111592, U1111-1122-0130 |
| Study First Received: | September 8, 2011 |
| Last Updated: | January 17, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases |
Endocrine System Diseases Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013