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NCT01431807 Clinical Trial

Long-term Study of SYR-472

Diabetes Mellitus Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01431807
Other study ID # SYR-472/OCT-001
Secondary ID JapicCTI-111592U
Status Completed
Phase Phase 3
First received
Last updated
Start date September 1, 2011
Est. completion date June 1, 2013

Study information
Verified date December 2023
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 680
Est. completion date June 1, 2013
Est. primary completion date June 1, 2013
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• SYR-472
oral, for up to 52 weeks.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Adverse events 52 weeks.
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