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

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ClinicalTrials.gov Identifier: NCT01387737

Recruitment Status : Completed

First Posted : July 6, 2011

Results First Posted : April 28, 2014

Last Update Posted : June 6, 2014

Sponsor:

Information provided by (Responsible Party):

Mitsubishi Tanabe Pharma Corporation

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Mellitus	Drug: TA-7284-Low Drug: TA-7284-High	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	1299 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	May 2011
Actual Primary Completion Date :	November 2012
Actual Study Completion Date :	December 2012

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Type 2 diabetes

MedlinePlus related topics: Safety

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: TA-7284-Low	Drug: TA-7284-Low TA-7284-Low
Experimental: TA-7284-High	Drug: TA-7284-High TA-7284-High

Outcome Measures

Primary Outcome Measures :

Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events [ Time Frame: 54 weeks ]

Secondary Outcome Measures :

Change in HbA1c [ Time Frame: Week 52 ]
Change in Fasting Plasma Glucose [ Time Frame: Week 52 ]
Change in Body Weight [ Time Frame: Week 52 ]
Change in Blood Pressure [ Time Frame: Week 52 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01387737

Locations

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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, Japan

Sponsors and Collaborators

Mitsubishi Tanabe Pharma Corporation

Investigators

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Study Director:	Nobuya Inagaki, M.D.	Kyoto University, Graduate School of Medicine
Study Director:	Kazuoki Kondo, M.D.	Mitsubishi Tanabe Pharma Corporation

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Inagaki N, Goda M, Yokota S, Maruyama N, Iijima H. Effects of Baseline Blood Pressure and Low-Density Lipoprotein Cholesterol on Safety and Efficacy of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Nov;32(11):1085-103. doi: 10.1007/s12325-015-0255-8. Epub 2015 Nov 3.

Inagaki N, Kondo K, Yoshinari T, Kuki H. Efficacy and safety of canagliflozin alone or as add-on to other oral antihyperglycemic drugs in Japanese patients with type 2 diabetes: A 52-week open-label study. J Diabetes Investig. 2015 Mar;6(2):210-8. doi: 10.1111/jdi.12266. Epub 2014 Aug 25.

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Responsible Party:	Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:	NCT01387737
Other Study ID Numbers:	TA-7284-06
First Posted:	July 6, 2011 Key Record Dates
Results First Posted:	April 28, 2014
Last Update Posted:	June 6, 2014
Last Verified:	May 2014

Keywords provided by Mitsubishi Tanabe Pharma Corporation:


TA-7284 JNJ-28431754 Canagliflozin Sodium Glucose Co-Transporter (SGLT2 inhibitor)

Additional relevant MeSH terms:

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Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases

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