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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
TA-7284
Placebo of TA-7284
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring Diabetes, TA-7284

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • P-One Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

TA-7284

Placebo of TA-7284

Arm Description

Outcomes

Primary Outcome Measures

Safety: Adverse Events, Adverse Drug Reactions
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
Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin

Full Information

First Posted
June 27, 2008
Last Updated
March 26, 2014
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00707954
Brief Title
Safety, Pharmacokinetics and Pharmacodynamics of TA-7284 in Type 2 Diabetic Patients
Official Title
A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Diabetes, TA-7284

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TA-7284
Arm Type
Experimental
Arm Title
Placebo of TA-7284
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
TA-7284
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo of TA-7284
Intervention Description
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 Outcome Measure Information:
Title
Safety: Adverse Events, Adverse Drug Reactions
Description
In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.
Time Frame
19 days
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
P-One Clinic
City
Hachioji-city
State/Province
Tokyo-to
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26280756
Citation
Iijima H, Kifuji T, Maruyama N, Inagaki N. Pharmacokinetics, Pharmacodynamics, and Safety of Canagliflozin in Japanese Patients with Type 2 Diabetes Mellitus. Adv Ther. 2015 Aug;32(8):768-82. doi: 10.1007/s12325-015-0234-0. Epub 2015 Aug 18.
Results Reference
derived

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

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