Clinical trial NCT01512849: A Study to Evaluate the PK/PD and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Official title: An Open-Label, Randomized, 2 Way Crossover, Single-Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of TA-7284 in Patients With Type 2 Diabetes Mellitus Who Have Moderate Renal Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes Mellitus
Keywords: TA-7284
JNJ-28431754
Canagliflozin
Renal Impairment
Sodium Glucose Co-transporter2 (SGLT2) inhibitor
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-01-19
Enrollment: 24
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment.

Detailed description: This is an open-label, randomized, 2-way crossover study to evaluate the PK/PD and safety of TA-7284 in patients with type 2 diabetes mellitus who have moderate renal impairment relative to patients with type 2 diabetes mellitus who have normal renal function. The patients will receive both TA-7284-Low and TA-7284-High orally alone in either Period 1 or 2.

Eligibility criteria: Inclusion Criteria:

* Patients with type 2 diabetes mellitus in stable condition who have normal renal function or moderate renal impairment
* Body mass index of ≥18.5 kg/m2 and ≤39.9 kg/m2 at screening
* HbA1c of ≥6.5% and ≤10.5% at screening

Exclusion Criteria:

* Type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
* Past or current history of severe diabetic complications
* Patients requiring insulin therapy
* History of hereditary glucose-galactose malabsorption or primary renal glucosuria

Primary outcomes:
measure: Effect of Renal Function on Maximum Plasma Concentration of TA-7284
timeFrame: For 72 hours after each administration
measure: Effect of Renal Function on Area Under the Plasma Concentration-time Curve From Zero up to Infinity of TA-7284
timeFrame: For 72 hours after each administration
measure: Effect of Renal Function on Urinary Glucose Excretion of TA-7284
timeFrame: For 24 hours after each administration
measure: Effect of Renal Function on Percent Inhibition of Renal Glucose Reabsorption (RGR) of TA-7284
timeFrame: For 24 hours after each administration
Secondary outcomes:
measure: Adverse Events
timeFrame: Upto approximately 14 days after last administration
measure: 12-lead Electrocardiogram (ECG)
timeFrame: For 72 hours after each administration
measure: Vital Signs
timeFrame: For 72 hours after each administration
measure: Clinical Laboratory Tests
timeFrame: For 72 hours after each administration
Other outcomes:
Locations:
city: Kanto
country: Japan
facility: Reserch site
Study officials:
affiliation: Kyoto University, Graduate School of Medicine
name: Nobuya Inagaki, MD
role: STUDY_DIRECTOR
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References: