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

April 2, 2019 updated by: Mitsubishi Tanabe Pharma Corporation

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • 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, Japan
        • Reserch site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Canagliflozin (TA-7284) ＋insulin
Drug: Insulin
Drug: Canagliflozin (TA-7284)
The patients will receive Canagliflozin orally for 36 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time Frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Percentage of HbA1c
Time Frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Change in Fasting Plasma Glucose
Time Frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Percentage Change in Body Weight
Time Frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitsubishi Tanabe Pharma Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (Actual)

April 1, 2016

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 2, 2015

First Submitted That Met QC Criteria

December 2, 2015

First Posted (Estimate)

December 4, 2015

Study Record Updates

Last Update Posted (Actual)

April 10, 2019

Last Update Submitted That Met QC Criteria

April 2, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-7284-13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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