Long-Term Safety Study of TA-7284 in Patients With Type 2 Diabetes Mellitus

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: TA-7284-High
Drug: TA-7284-Low

Study type

Interventional

Funder types

Industry

Identifiers

NCT01387737
TA-7284-06

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of TA-7284 as monotherapy or combination therapy with other oral anti-hyperglycaemic agent in Japanese patients with Type 2 diabetes mellitus on 52 weeks oral administration.

Full description

This is a randomized, 2-arm, parallel group, open-label study to evaluate the safety and efficacy of TA-7284 in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise or with oral anti-hyperglycaemic agent. The patients will receive either TA-7284-Low or TA-7284-High orally alone or in combination with oral anit-hyperglycaemic agent for 52 weeks.

Enrollment

1,299 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 screening
  • HbA1c of ≥7.0% and ≤10.0% (monotherapy group)
  • HbA1c of ≥7.0% and ≤10.5% (combination therapy group)

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

1,299 participants in 2 patient groups

TA-7284-Low
Experimental group
Treatment:
Drug: TA-7284-Low
TA-7284-High
Experimental group
Treatment:
Drug: TA-7284-High

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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