Efficacy and Safety Study of TA-7284 in Patients With Type 2 Diabetes

Tanabe Pharma Corporation

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: Placebo; Drug: TA-7284 Low; Drug: TA-7284 High

Study type: Interventional

Funder types: Industry

Identifiers

NCT01413204

TA-7284-05

Details and patient eligibility

About

The purpose of this study is to evaluate the efficacy and safety of TA-7284 as monotherapy in patients with type 2 Diabetes for 24 weeks administration.

Full description

This is a randomized, 3-arm, parallel group, double blind study to evaluate the efficacy and safety of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will receive either TA-7284-Low, TA-7284-High or Placebo orally alone for 24 weeks.

Enrollment: 272 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men or women age ≥20 years old
• Diagnosed with Type 2 diabetes mellitus at least 3 months before run-in period
• HbA1c of ≥7.0% and ≤10.0%

Exclusion criteria

• Type I diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus
• Past or current history of severe diabetic complications
• Fasting plasma glucose > 270 mg/dL before treatment start
• History of hereditary glucose-galactose malabsorption or primary renal glucosuria
• Patients requiring insulin therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

272 participants in 3 patient groups, including a placebo group

TA-7284 Low

Experimental group

Treatment:

Drug: TA-7284 Low

TA-7284 High

Experimental group

Treatment:

Drug: TA-7284 High

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo