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Completed

NCT Number: NCT01413204

Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 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

Reserch site, Chūbu, Japan

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About this study

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women age ≥20 years old
  • Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
  • HbA1c of ≥7.0% and ≤10.0%

Exclusion criteria

  • Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
  • Past or current history of severe diabetic complications
  • Fasting plasma glucose > 270 mg/dL before treatment start
  • History of hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients requiring insulin therapy

Treatment and study plan

TA-7284 Low

Drug

The patients will receive TA-7284-Low orally for 24 weeks.

TA-7284 High

Drug

The patients will receive TA-7284-High orally for 24 weeks.

Placebo

Drug

The patients will receive Placebo orally for 24 weeks.

Primary outcomes

  1. Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)

    Time frame: baseline and 24 weeks

Secondary outcomes

  1. Change in Fasting Plasma Glucose

    Time frame: Week 24

  2. Change in Body Weight

    Time frame: Week 24

  3. Change in Blood Pressure

    Time frame: Week 24

  4. Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test

    Time frame: Week 24

  5. Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs

    Time frame: Week 24

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of TA-7284 as Monotherapy in the Treatment of Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Aug 10, 2011
Registry last updated
Jan 8, 2026

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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