Long-term Study of SYR-472

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01431807
First received: September 8, 2011
Last updated: November 5, 2013
Last verified: November 2013

September 8, 2011
November 5, 2013
September 2011
June 2013   (final data collection date for primary outcome measure)
Adverse events [ Time Frame: 52 weeks. ] [ Designated as safety issue: Yes ]
Adverse events [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01431807 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long-term Study of SYR-472
An Open-label, Multicenter, Long-term Phase 3 Study to Evaluate the Safety and Efficacy of Long-term Treatment With SYR-472 in the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control Despite Diet and/or Exercise Therapies or Treatment With an Existing Oral Anti-diabetic Drug Added to Diet and/or Exercise Therapies

To evaluate the safety and efficacy of long-term treatment with SYR-472 in diabetic patients.

Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus
Drug: SYR-472
oral, for up to 52 weeks.
Experimental: SYR-472 group
(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)
Intervention: Drug: SYR-472
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
680
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. The participant is an outpatient.
  2. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.
  3. Diabetes Mellitus

Exclusion Criteria:

  1. The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  2. The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01431807
SYR-472/OCT-001, JapicCTI-111592, U1111-1122-0130
No
Takeda
Takeda
Not Provided
Study Director: Senior Director Takeda
Takeda
November 2013

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