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

Type 2 Diabetes Mellitus Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01413204
• Other study ID #: TA-7284-05
• Status: Completed
• Phase: Phase 3
• First received: August 4, 2011
• Last updated: May 27, 2014
• Start date: July 2011
• Est. completion date: August 2012

Study information

• Verified date: May 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 272
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• TA-7284 Low
The patients will receive TA-7284-Low orally for 24 weeks.
• TA-7284 High
The patients will receive TA-7284-High orally for 24 weeks.
• Placebo
The patients will receive Placebo orally for 24 weeks.

Locations

Country	Name	City	State
Japan	Reserch site	Chubu
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki
Japan	Reserch site	Shikoku
Japan	Reserch site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)		baseline and 24 weeks	No
Secondary	Change in Fasting Plasma Glucose		Week 24	No
Secondary	Change in Body Weight		Week 24	No
Secondary	Change in Blood Pressure		Week 24	No
Secondary	Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test		Week 24	No
Secondary	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs		Week 24	Yes