Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

Type 2 Diabetes Mellitus Clinical Trial

Official title:

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of TA-7284 in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01387737
• Other study ID #: TA-7284-06
• Status: Completed
• Phase: Phase 3
• First received: June 28, 2011
• Last updated: May 27, 2014
• Start date: May 2011
• Est. completion date: December 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 safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Description:

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1299
• Est. completion date: December 2012
• Est. primary completion date: November 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 screening

• HbA1c of =7.0% and =10.0% (monotherapy group)

• HbA1c of =7.0% and =10.5% (combination therapy group)

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: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• TA-7284-Low
TA-7284-Low
• TA-7284-High
TA-7284-High

Locations

Country	Name	City	State
Japan	Research site	Chugoku
Japan	Research site	Hokkaido
Japan	Research site	Kanto
Japan	Research site	Kinki
Japan	Research site	Kyushu
Japan	Research site	Shikoku
Japan	Research 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	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events		54 weeks	Yes
Secondary	Change in HbA1c		Week 52	No
Secondary	Change in Fasting Plasma Glucose		Week 52	No
Secondary	Change in Body Weight		Week 52	No
Secondary	Change in Blood Pressure		Week 52	No