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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01686711
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : May 20, 2014
Information provided by (Responsible Party):

Brief Summary:
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Drug: AD-4833 15 mg Drug: AD-4833 30 mg Drug: Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
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
Study Start Date : September 2012
Primary Completion Date : December 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Glycosylated Hemoglobin (HbA1c) [ Time Frame: 16 weeks ]
    Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01686711

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
Study Director: General Manager Takeda

Responsible Party: Takeda Identifier: NCT01686711     History of Changes
Other Study ID Numbers: SYR-322-4833/CCT-901
U1111-1132-3209 ( Registry Identifier: WHO )
JapicCTI-121916 ( Registry Identifier: JapicCTI )
First Posted: September 18, 2012    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014

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