A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322

This study is currently recruiting participants.
Verified June 2013 by Takeda
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01686711
First received: August 31, 2012
Last updated: June 17, 2013
Last verified: June 2013
  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:

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
Recruiting
Hirosaki-shi, Aomori, Japan
Recruiting
Kisaratsu-shi, Chiba, Japan
Recruiting
Matsuyama-shi, Ehime, Japan
Recruiting
Fukuoka-shi, Fukuoka, Japan
Recruiting
Kitakyushu-shi, Fukuoka, Japan
Recruiting
Kurume-shi, Fukuoka, Japan
Recruiting
Fukuyama-shi, Hiroshima, Japan
Recruiting
Hiroshima-shi, Hiroshima, Japan
Recruiting
Sapporo-shi, Hokkaido, Japan
Recruiting
Koga-shi, Ibaraki, Japan
Recruiting
Yokohama-shi, Kanagawa, Japan
Recruiting
Kumamoto-shi, Kumamoto, Japan
Recruiting
Miyazaki-shi, Miyazaki, Japan
Recruiting
Suita-shi, Osaka, Japan
Recruiting
Koshigaya-shi, Saitama, Japan
Recruiting
Otsu-shi, Shiga, Japan
Recruiting
Chiyoda-ku, Tokyo, Japan
Recruiting
Chuo-ku, Tokyo, Japan
Recruiting
Itabashi-ku, Tokyo, Japan
Recruiting
Meguro-ku, Tokyo, Japan
Recruiting
Minato-ku, Tokyo, Japan
Recruiting
Ohta-ku, Tokyo, Japan
Recruiting
Shinjuku-ku, Tokyo, Japan
Recruiting
Toyama-shi, Toyama, Japan
Recruiting
Shimonoseki-shi, Yamaguchi, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Director: General Manager Takeda
  More Information

No publications provided

Responsible Party: Takeda
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: June 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 April 17, 2014