ClinicalTrials.Veeva

Menu

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

Mitsubishi Tanabe Pharma logo

Mitsubishi Tanabe Pharma

Status and phase

Completed
Phase 4

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: Canagliflozin (TA-7284)
Drug: Insulin

Study type

Interventional

Funder types

Industry

Identifiers

NCT02622113
TA-7284-13

Details and patient eligibility

About

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

Full description

This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Enrollment

139 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)

Exclusion criteria

  • Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
  • Patients with serious renal or hepatic disease
  • Patients who are the excessive alcohol addicts
  • Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

139 participants in 1 patient group

Canagliflozin (TA-7284) +insulin
Experimental group
Treatment:
Drug: Insulin
Drug: Canagliflozin (TA-7284)

Trial contacts and locations

7

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems