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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00707954
• Other study ID #: TA-7284-02
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: June 27, 2008
• Last updated: March 26, 2014
• Start date: June 2008
• Est. completion date: February 2009

Study information

• Verified date: March 2014
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• TA-7284
Patients will receive single ascending dose of TA-7284 in each step (4 doses planned: 25, 100, 200 and 400 mg), once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)
• Placebo of TA-7284
Patients will receive placebo tablets in each step, once daily, 15 days (1 day followed by a 1 day washout period and then 14 consecutive days)

Locations

Country	Name	City	State
Japan	P-One Clinic	Hachioji-city	Tokyo-to

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Adverse Events, Adverse Drug Reactions	In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.	19 days	Yes
Secondary	Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr		19 days	No
Secondary	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	No