Study of Combination Therapy With 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:
NCT01521962
First received: January 26, 2012
Last updated: January 17, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
To determine the efficacy and safety of SYR-322 (alogliptin) 25-mg, once daily (QD), in patients with diabetes when used in combination with insulin.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus |
Drug: Alogliptin Drug: Insulin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment |
| Official Title: | A Phase 3 Study to Investigate the Efficacy and Safety of SYR-322 When Used in Combination With Insulin Preparation in Subjects With Type 2 Diabetes in Japan |
Resource links provided by NLM:
Further study details as provided by Takeda Global Research & Development Center, Inc.:
Primary Outcome Measures:
- Change in glycosylated hemoglobin (HbA1c; Japan Diabetes Society value) [ Time Frame: Baseline and Week 12 ]
| Estimated Enrollment: | 168 |
| Study Start Date: | February 2012 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: SYR-322 (Alogliptin) QD
SYR-322 25 mg, orally.
|
Drug: Alogliptin
Alogliptin tablets
Other Name: SYR-322
|
|
Placebo Comparator: Insulin
injection
|
Drug: Insulin
Insulin injection
|
Eligibility| Ages Eligible for Study: | 20 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- The subject is an outpatient.
- The subject signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
Exclusion Criteria:
- The subject has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
- The subject 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: NCT01521962
Contacts
| Contact: Takeda Study Registration Call Center | 800-778-2860 | medicalinformation@tpna.com |
Locations
| Japan | |
| Active, not recruiting | |
| Aomori-shi, Aomori, Japan | |
| Recruiting | |
| Hirosaki-shi, Aomori, Japan | |
| Recruiting | |
| Kashiwa-shi, Chiba, Japan | |
| Recruiting | |
| Kisarazu-shi, Chiba, Japan | |
| Recruiting | |
| Kitakyushu-shi, Fukuoka, Japan | |
| Recruiting | |
| Aki-gun, Hiroshima, Japan | |
| Recruiting | |
| Fukuyama-shi, Hiroshima, Japan | |
| Not yet recruiting | |
| Nishinomiya-shi, Hyogo, Japan | |
| Recruiting | |
| Koga-shi, Ibaraki, Japan | |
| Recruiting | |
| Ushiku-shi, Ibaraki, Japan | |
| Recruiting | |
| Kahoku-gun, Ishikawa, Japan | |
| Recruiting | |
| Hanamaki-shi, Iwate, Japan | |
| Active, not recruiting | |
| Morioka-shi, Iwate, Japan | |
| Active, not recruiting | |
| Kagoshima-shi, Kagoshima, Japan | |
| Recruiting | |
| Satsuma-sendai-shi, Kagoshima, Japan | |
| Recruiting | |
| Kumamoto-shi, Kumamoto, Japan | |
| Recruiting | |
| Minamata-shi, Kumamoto, Japan | |
| Recruiting | |
| Miyazaki-shi, Miyazaki, Japan | |
| Active, not recruiting | |
| Nigata-shi, Nigata, Japan | |
| Recruiting | |
| Hirakata-shi, Osaka, Japan | |
| Active, not recruiting | |
| Osaka-sayama-shi, Osaka, Japan | |
| Recruiting | |
| Osaka-shi, Osaka, Japan | |
| Recruiting | |
| Takatsuki-shi, Osaka, Japan | |
| Recruiting | |
| Yao-shi, Osaka, Japan | |
| Recruiting | |
| Kuki-shi, Saitama, Japan | |
| Recruiting | |
| Otsu-shi, Shiga, Japan | |
| Recruiting | |
| Hamamatsu-shi, Shizuoka, Japan | |
| Recruiting | |
| Shizuoka-shi, Shizuoka, Japan | |
| Recruiting | |
| Shimotsuke-shi, Tochigi, Japan | |
| Recruiting | |
| Shinagawa-ku, Tokyo, Japan | |
| Recruiting | |
| Toyama-shi, Toyama, Japan | |
| Active, not recruiting | |
| Sagae-shi, Yamagata, Japan | |
| Active, not recruiting | |
| Yamagata-shi, Yamagata, Japan | |
Sponsors and Collaborators
Takeda Pharmaceutical Company Limited
Investigators
| Study Director: | Senior 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: | NCT01521962 History of Changes |
| Other Study ID Numbers: | SYR-322/CCT-901, U1111-1127-1525, JapicCTI-121736 |
| Study First Received: | January 26, 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 Insulin 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