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

NCT00707954 | Completed Phase 1 Results

• 1 other identifier: TA-7284-02
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Diabetes; TA-7284

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

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

  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

  18 days

Study Arms (2)

TA-7284

EXPERIMENTAL

Drug: TA-7284

Placebo of TA-7284

PLACEBO COMPARATOR

Drug: Placebo of TA-7284

Interventions

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)

TA-7284

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)

Placebo of TA-7284

Eligibility Criteria

• Age: 25 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (1)

P-One Clinic

Hachiōji, Tokyo-to, Japan

Location

Related Publications (1)

• 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.

  PMID: 26280756 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2008
• First Posted: July 1, 2008
• Study Start: June 1, 2008
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: January 8, 2026
• Results First Posted: April 28, 2014

Record last verified: 2025-12

Locations

JP (1)