Phase 2 Completed N=61 Randomized Quadruple-blind Treatment

Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients

Source: ClinicalTrials.gov NCT00707954 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcomePrimary: Safety: Adverse Events, Adverse Drug Reactions — 75.0; 66.7; 35.7; 46.2 percentage of incidences

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety: Adverse Events, Adverse Drug Reactions	75.0; 66.7; 35.7; 46.2; 80.0; 50.0	—
SECONDARY Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr	—	—
SECONDARY Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin	—	—

Eligibility Criteria

Inclusion Criteria

Clinically stable Type 2 Diabetes Mellitus
Females without childbearing potential
Body mass index (BMI) >= 18.5 kg/m2 and = 6.5% and = 140 mg/dL and = 95 mmHg and = 50 mmHg and = 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

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Data sourced from ClinicalTrials.gov (NCT00707954). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.