Clinical trial NCT01413204: Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes
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
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: 2011-08-10
Enrollment: 272
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 efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hemoglobin A1c (A1C) From Baseline (NGSP Value)
timeFrame: baseline and 24 weeks
Secondary outcomes:
measure: Change in Fasting Plasma Glucose
timeFrame: Week 24
measure: Change in Body Weight
timeFrame: Week 24
measure: Change in Blood Pressure
timeFrame: Week 24
measure: Change in Postprandial Plasma Glucose, Insulin and Urinary Glucose Excretion After a 75 g Oral Glucose Tolerance Test
timeFrame: Week 24
measure: Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events, Laboratory Tests, 12-lead ECG and Vital Signs
timeFrame: Week 24
Other outcomes:
Locations:
city: Chubu
country: Japan
facility: Reserch site
city: Kanto
country: Japan
facility: Reserch site
city: Kinki
country: Japan
facility: Reserch site
city: Shikoku
country: Japan
facility: Reserch site
city: Tohoku
country: Japan
facility: Reserch 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, Kondo K, Yoshinari T, Takahashi N, Susuta Y, Kuki H. Efficacy and safety of canagliflozin monotherapy in Japanese patients with type 2 diabetes inadequately controlled with diet and exercise: a 24-week, randomized, double-blind, placebo-controlled, Phase III study. Expert Opin Pharmacother. 2014 Aug;15(11):1501-15. doi: 10.1517/14656566.2014.935764.