Clinical trial NCT00707954: Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
Official title: A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Type 2 Diabetes Mellitus
Keywords: Diabetes
TA-7284
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2008-07-01
Enrollment: 61
Sex: ALL
Minimum age (years): 25
Maximum age (years): 65
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, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.


Eligibility criteria: Inclusion Criteria:

* Clinically stable Type 2 Diabetes Mellitus
* Females without childbearing potential
* Body mass index (BMI) \>= 18.5 kg/m2 and \<= 39.9 kg/m2
* Hemoglobin A1c levels \>= 6.5% and \<= 10%
* Fasting blood glucose levels \>= 140 mg/dL and \<= 270 mg/dL
* Systolic blood pressure \>= 95 mmHg and \<= 160 mmHg, and diastolic blood pressure \>= 50 mmHg and \<= 100 mmHg, and pulse rate \>= 50 bpm
* Patients who have not been administered anti-diabetic medication within 2 weeks Prior to dosing
* Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months
* Treatment with diet and exercise should be unchanged for more than 3 months

Exclusion Criteria:

* Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
* History of diabetic complications which need treatment
* Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
* Serum creatinine \> upper limit of the normal range
* Patients with significant complications

Primary outcomes:
measure: Safety: Adverse Events, Adverse Drug Reactions
timeFrame: 19 days
Secondary outcomes:
measure: Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr
timeFrame: 19 days
measure: Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin
timeFrame: 18 days
Other outcomes:
Locations:
city: Hachioji-city
country: Japan
facility: P-One Clinic
state: Tokyo-to
Study officials:
affiliation: Mitsubishi Tanabe Pharma Corporation
name: Kazuoki Kondo, MD
role: STUDY_DIRECTOR
References:
citation: Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18.