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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.
 
ClinicalTrials.gov Identifier: NCT01686711
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : May 20, 2014
Sponsor:
Information provided by (Responsible Party):
Takeda

Tracking Information
First Submitted Date  ICMJE August 31, 2012
First Posted Date  ICMJE September 18, 2012
Last Update Posted Date May 20, 2014
Study Start Date  ICMJE September 2012
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 12, 2012)
Glycosylated Hemoglobin (HbA1c) [ Time Frame: 16 weeks ]
Measurement of change in HbA1c (ratio of hemoglobin bound to glucose)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Double-blind, Parallel Group, Comparative Study of Coadministration AD-4833 and SYR-322
Official Title  ICMJE 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
Brief Summary To evaluate the efficacy and safety of coadministration AD-4833 and SYR-322 in patients with diabetes mellitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus
Intervention  ICMJE
  • Drug: AD-4833 15 mg
  • Drug: AD-4833 30 mg
  • Drug: Placebo
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 12, 2012)
207
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2013
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01686711
Other Study ID Numbers  ICMJE SYR-322-4833/CCT-901
U1111-1132-3209 ( Registry Identifier: WHO )
JapicCTI-121916 ( Registry Identifier: JapicCTI )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Takeda
Study Sponsor  ICMJE Takeda
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: General Manager Takeda
PRS Account Takeda
Verification Date May 2014

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