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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01686711
First received: August 31, 2012
Last updated: May 16, 2014
Last verified: May 2014
  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: Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: A Phase 4, Multicenter, Randomized, Double-blind, Parallel-group, Comparative Study to Evaluate the Efficacy and Safety of AD-4833 When Orally Administered Once Daily as add-on to SYR-322 Versus SYR-322 Alone in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Treatment With SYR-322 in Addition to Diet and/or Exercise Therapy

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)


Enrollment: 207
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01686711

Locations
Japan
Hirosaki-shi, Aomori, Japan
Kisaratsu-shi, Chiba, Japan
Matsuyama-shi, Ehime, Japan
Fukuoka-shi, Fukuoka, Japan
Kitakyushu-shi, Fukuoka, Japan
Kurume-shi, Fukuoka, Japan
Fukuyama-shi, Hiroshima, Japan
Hiroshima-shi, Hiroshima, Japan
Sapporo-shi, Hokkaido, Japan
Koga-shi, Ibaraki, Japan
Yokohama-shi, Kanagawa, Japan
Kumamoto-shi, Kumamoto, Japan
Miyazaki-shi, Miyazaki, Japan
Suita-shi, Osaka, Japan
Koshigaya-shi, Saitama, Japan
Otsu-shi, Shiga, Japan
Chiyoda-ku, Tokyo, Japan
Chuo-ku, Tokyo, Japan
Itabashi-ku, Tokyo, Japan
Meguro-ku, Tokyo, Japan
Minato-ku, Tokyo, Japan
Ohta-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Toyama-shi, Toyama, Japan
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: May 16, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Alogliptin
Pioglitazone
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Incretins
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors

ClinicalTrials.gov processed this record on October 23, 2014