Double-blind Comparative Study of SYR-472
This study is currently recruiting participants.
Verified January 2013 by Takeda Global Research & Development Center, Inc.
Sponsor:
Takeda Pharmaceutical Company Limited
Information provided by (Responsible Party):
Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited )
ClinicalTrials.gov Identifier:
NCT01632007
First received: June 27, 2012
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: SYR-472 Drug: Alogliptin 25 mg Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Glycosylated hemoglobin (HbA1c) [ Time Frame: 24 weeks. ] [ Designated as safety issue: No ]Measurement of change in HbA1c (ratio of hemoglobin bound to glucose).
| Estimated Enrollment: | 240 |
| Study Start Date: | May 2012 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SYR-472 100 mg | Drug: SYR-472 |
| Active Comparator: Alogliptin 25 mg |
Drug: Alogliptin 25 mg
Other Name: SYR-322
|
| Placebo Comparator: Placebo | Drug: Placebo |
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.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period)
- 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: NCT01632007
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Japan | |
| Recruiting | |
| Akita-shi, Akita, Japan | |
| Recruiting | |
| Matsudo-shi, Chiba, Japan | |
| Recruiting | |
| Fukuoka-shi, Fukuoka, Japan | |
| Recruiting | |
| Fukuyama-shi, Hiroshima, Japan | |
| Recruiting | |
| Ishikari-shi, Hokkaido, Japan | |
| Recruiting | |
| Nakagawa-gun, Hokkaido, Japan | |
| Recruiting | |
| Sapporo-shi, Hokkaido, Japan | |
| Recruiting | |
| Naka-shi, Ibaragi, Japan | |
| Recruiting | |
| Sagamihara-shi, Kanagawa, Japan | |
| Recruiting | |
| Kumamoto-shi, Kumamoto, Japan | |
| Recruiting | |
| Kashiwara-shi, Osaka, Japan | |
| Recruiting | |
| Osaka-shi, Osaka, Japan | |
| Recruiting | |
| Suita-shi, Osaka, Japan | |
| Active, not recruiting | |
| Arakawa-ku, Tokyo, Japan | |
| Recruiting | |
| Bunkyo-ku, Tokyo, Japan | |
| Recruiting | |
| Chiyoda-ku, Tokyo, Japan | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan | |
| Recruiting | |
| Itabashi-ku, Tokyo, Japan | |
| Recruiting | |
| Katsushika-ku, Tokyo, Japan | |
| Recruiting | |
| Mitaka-shi, Tokyo, Japan | |
| Recruiting | |
| Shinjuku-ku, Tokyo, Japan | |
| Recruiting | |
| Shonan-shi, Yamaguchi, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | Medical Director | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01632007 History of Changes |
| Other Study ID Numbers: | SYR-472/CCT-002, U1111-1128-6104, JapicCTI-121839 |
| Study First Received: | June 27, 2012 |
| Last Updated: | January 17, 2013 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Additional relevant MeSH terms:
|
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Alogliptin Dipeptidyl-Peptidase IV Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Hypoglycemic Agents Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 22, 2013