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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02220920
• Other study ID #: TA-7284-11
• Status: Completed
• Phase: Phase 4
• First received: August 19, 2014
• Last updated: December 20, 2015
• Start date: August 2014
• Est. completion date: July 2015

Study information

• Verified date: December 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.

Description:

This is a randomized, 2-arm, parallel group, double blind study to evaluate the efficacy and safety of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with insulin therapy on diet and exercise and have inadequate glycemic control. The patients will receive either TA-7284 100mg or Placebo orally for 16 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 146
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Patients who has been receiving a stable dose and regimen of insulin over 12 weeks before administration of investigational dug

• Patients who are under dietary management and taking therapeutic exercise for diabetes over 12 weeks before administration of investigational drug

• Patients with HbA1c of =7.5% and <10.5%

• Patients who were not administered diabetes therapeutic drugs prohibited for concomitant use within 12 weeks before administration of investigational drug

Exclusion Criteria:

• Patients with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, or secondary diabetes mellitus (Cushing's syndrome, acromegaly, etc.)

• Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)

• Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria

• Patients with systolic blood pressure of =160 mmHg or diastolic blood pressure of =100 mmHg

• Patients with serious renal or hepatic disease

• Patients with eGFR of <45 mL/min/1.73 m2

• Patients who are the excessive alcohol addicts

• Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Canagliflozin (TA-7284) +insulin
The patients will receive Canagliflozin orally for 16 weeks
• Placebo+insulin
The patients will receive Placebo orally for 16 weeks

Locations

Country	Name	City	State
Japan	Reserch site	Chubu
Japan	Reserch site	Chugoku
Japan	Reserch site	Hokkaido
Japan	Reserch site	Kanto
Japan	Reserch site	Kinki
Japan	Reserch site	Kyushu
Japan	Reserch site	Tohoku

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1c from Baseline		baseline and Week 16	No
Secondary	Change in Fasting plasma glucose		baseline and Week 16	No
Secondary	Change in Body Weight		baseline and Week 16	No
Secondary	Change in Blood pressure		baseline and Week 16	No
Secondary	Safety and Tolerability Assessed by Adverse Events, Hypoglycemic Events		Week 16	No