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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT00707954
First received: June 27, 2008
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: TA-7284
Drug: Placebo of TA-7284
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Safety: Adverse Events, Adverse Drug Reactions [ Time Frame: 19 days ] [ Designated as safety issue: Yes ]
    In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: June 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TA-7284 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 Comparator: Placebo of TA-7284 Drug: 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)

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00707954

Locations
Japan
P-One Clinic
Hachioji-city, Tokyo-to, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT00707954     History of Changes
Other Study ID Numbers: TA-7284-02
Study First Received: June 27, 2008
Results First Received: March 26, 2014
Last Updated: March 26, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetes
TA-7284

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 29, 2014