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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01686711
First Posted: September 18, 2012
Last Update Posted: May 20, 2014
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.
Information provided by (Responsible Party):
Takeda
August 31, 2012
September 18, 2012
May 20, 2014
September 2012
December 2013   (Final data collection date for primary outcome measure)
Glycosylated Hemoglobin (HbA1c) [ Time Frame: 16 weeks ]
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
Same as current
Complete list of historical versions of study NCT01686711 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322
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
To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
Not Provided
Interventional
Phase 4
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Diabetes Mellitus
  • Drug: AD-4833 15 mg
  • Drug: AD-4833 30 mg
  • Drug: Placebo
  • Experimental: SYR-322 25 mg , AD-4833 15 mg
    Intervention: Drug: AD-4833 15 mg
  • Experimental: SYR-322 25 mg , AD-4833 30 mg
    Intervention: Drug: AD-4833 30 mg
  • Placebo Comparator: SYR-322 25 mg , AD-4833 placebo
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
207
December 2013
December 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
20 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
 
NCT01686711
SYR-322-4833/CCT-901
U1111-1132-3209 ( Registry Identifier: WHO )
JapicCTI-121916 ( Registry Identifier: JapicCTI )
No
Not Provided
Not Provided
Takeda
Takeda
Not Provided
Study Director: General Manager Takeda
Takeda
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP