Clinical trial NCT01387737: Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284
JNJ-28431754
Canagliflozin
Sodium Glucose Co-Transporter (SGLT2 inhibitor)
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2011-07-06
Enrollment: 1299
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events
timeFrame: 54 weeks
Secondary outcomes:
measure: Change in HbA1c
timeFrame: Week 52
measure: Change in Fasting Plasma Glucose
timeFrame: Week 52
measure: Change in Body Weight
timeFrame: Week 52
measure: Change in Blood Pressure
timeFrame: Week 52
Other outcomes:
Locations:
city: Chugoku
country: Japan
facility: Research site
city: Hokkaido
country: Japan
facility: Research site
city: Kanto
country: Japan
facility: Research site
city: Kinki
country: Japan
facility: Research site
city: Kyushu
country: Japan
facility: Research site
city: Shikoku
country: Japan
facility: Research site
city: Tohoku
country: Japan
facility: Research site
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Nobuya Inagaki, M.D.
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, M.D.
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.