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

Phase 1

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: TA-7284; Drug: Placebo of TA-7284

• Registration Number: NCT00707954
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-27
• Study First Submitted QC: 2008-06-27
• Study First Posted: 2008-07-01
• Primary Completion: 2009-02
• Study Completion: 2009-02
• Status Verified: 2014-03
• Results First Submitted: 2014-03-26
• Results First Submitted QC: 2014-03-26
• Last Update Submitted: 2014-03-26
• Results First Posted: 2014-04-28
• Last Update Posted: 2014-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TA-7284	TA-7284	-
Placebo of TA-7284	Placebo of TA-7284	-

Primary Outcome Measures

Name	Time	Method
Safety: Adverse Events, Adverse Drug Reactions	19 days	In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr	19 days
Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin	18 days

Trial Locations

Locations (1)

P-One Clinic; 🇯🇵 Hachioji-city, Tokyo-to, Japan