- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00707954
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
March 26, 2014 updated by: Mitsubishi Tanabe Pharma Corporation
A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tokyo-to
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Hachioji-city, Tokyo-to, Japan
- P-one Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
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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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
19 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
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
Time Frame: 18 days
|
18 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2008
Primary Completion (Actual)
February 1, 2009
Study Completion (Actual)
February 1, 2009
Study Registration Dates
First Submitted
June 27, 2008
First Submitted That Met QC Criteria
June 27, 2008
First Posted (Estimate)
July 1, 2008
Study Record Updates
Last Update Posted (Estimate)
April 28, 2014
Last Update Submitted That Met QC Criteria
March 26, 2014
Last Verified
March 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-7284-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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