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NCT Number: NCT00707954

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

P-One Clinic

Hachiōji, Tokyo-to, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TA-7284

Drug

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

Drug

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)

Primary outcomes

  1. Safety: Adverse Events, Adverse Drug Reactions

    Time frame: 19 days

    In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.

Secondary outcomes

  1. Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr

    Time frame: 19 days

  2. Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin

    Time frame: 18 days

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 1, 2008
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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