Long-term Study of SYR-472

Phase 3

Completed

• Conditions: Diabetes Mellitus
• Interventions: Drug: SYR-472

• Registration Number: NCT01431807
• Lead Sponsor: Takeda

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09-01
• Study First Submitted: 2011-09-08
• Study First Submitted QC: 2011-09-09
• Study First Posted: 2011-09-12
• Primary Completion: 2013-06-01
• Study Completion: 2013-06-01
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-07
• Last Update Posted: 2023-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 680

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SYR-472 group	SYR-472	(long-term monotherapy or long-term combination therapy with anti-diabetic drugs)

Primary Outcome Measures

Name	Time	Method
Adverse events	52 weeks.