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OpenTrials
Completed

NCT Number: NCT01431807

Long-term Study of SYR-472

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Akita, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.
  • The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

Treatment and study plan

SYR-472

Drug

oral, for up to 52 weeks.

Primary outcomes

  1. Adverse events

    Time frame: 52 weeks.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 12, 2011
Registry last updated
Dec 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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