A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322
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:
NCT01686711
First received: August 31, 2012
Last updated: January 17, 2013
Last verified: January 2013
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Purpose
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: AD-4833 15 mg Drug: AD-4833 30 mg Drug: Placebo |
Phase 4 |
| 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: 16 weeks ] [ Designated as safety issue: No ]Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
| Estimated Enrollment: | 207 |
| Study Start Date: | September 2012 |
| Arms | Assigned Interventions |
|---|---|
| Experimental: SYR-322 25 mg , AD-4833 15 mg | Drug: AD-4833 15 mg |
| Experimental: SYR-322 25 mg , AD-4833 30 mg | Drug: AD-4833 30 mg |
| Placebo Comparator: SYR-322 25 mg , AD-4833 placebo | Drug: Placebo |
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686711
Contacts
| Contact: Takeda Study Registration Call Center | +1-800-778-2860 | medicalinformation@tpna.com |
Locations
| Japan | |
| Not yet recruiting | |
| Hirosaki-shi, Aomori, Japan | |
| Not yet recruiting | |
| Kisaratsu-shi, Chiba, Japan | |
| Not yet recruiting | |
| Matsuyama-shi, Ehime, Japan | |
| Not yet recruiting | |
| Fukuoka-shi, Fukuoka, Japan | |
| Not yet recruiting | |
| Kitakyushu-shi, Fukuoka, Japan | |
| Recruiting | |
| Kurume-shi, Fukuoka, Japan | |
| Not yet recruiting | |
| Fukuyama-shi, Hiroshima, Japan | |
| Not yet recruiting | |
| Hiroshima-shi, Hiroshima, Japan | |
| Not yet recruiting | |
| Sapporo-shi, Hokkaido, Japan | |
| Not yet recruiting | |
| Koga-shi, Ibaraki, Japan | |
| Recruiting | |
| Yokohama-shi, Kanagawa, Japan | |
| Recruiting | |
| Kumamoto-shi, Kumamoto, Japan | |
| Recruiting | |
| Miyazaki-shi, Miyazaki, Japan | |
| Not yet recruiting | |
| Suita-shi, Osaka, Japan | |
| Not yet recruiting | |
| Koshigaya-shi, Saitama, Japan | |
| Not yet recruiting | |
| Otsu-shi, Shiga, Japan | |
| Not yet recruiting | |
| Chiyoda-ku, Tokyo, Japan | |
| Recruiting | |
| Chuo-ku, Tokyo, Japan | |
| Recruiting | |
| Itabashi-ku, Tokyo, Japan | |
| Not yet recruiting | |
| Meguro-ku, Tokyo, Japan | |
| Not yet recruiting | |
| Minato-ku, Tokyo, Japan | |
| Recruiting | |
| Ohta-ku, Tokyo, Japan | |
| Not yet recruiting | |
| Shinjuku-ku, Tokyo, Japan | |
| Not yet recruiting | |
| Toyama-shi, Toyama, Japan | |
| Not yet recruiting | |
| Shimonoseki-shi, Yamaguchi, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | General Manager | Takeda Pharmaceutical Company Limited |
More Information
No publications provided
| Responsible Party: | Takeda Global Research & Development Center, Inc. ( Takeda Pharmaceutical Company Limited ) |
| ClinicalTrials.gov Identifier: | NCT01686711 History of Changes |
| Other Study ID Numbers: | SYR-322-4833/CCT-901, U1111-1132-3209, JapicCTI-121916 |
| Study First Received: | August 31, 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 Pioglitazone Alogliptin Hypoglycemic Agents |
Physiological Effects of Drugs Pharmacologic Actions Dipeptidyl-Peptidase IV Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013