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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Canagliflozin (TA-7284)
Insulin
Sponsored by
Mitsubishi Tanabe Pharma Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring insulin resistance

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canagliflozin (TA-7284) ＋insulin

Arm Description

Outcomes

Primary Outcome Measures

Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)

Secondary Outcome Measures

Change in Percentage of HbA1c
Change in Fasting Plasma Glucose
Percentage Change in Body Weight

Full Information

First Posted
December 2, 2015
Last Updated
April 2, 2019
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02622113
Brief Title
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mitsubishi Tanabe Pharma Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin (TA-7284) ＋insulin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Canagliflozin (TA-7284)
Intervention Description
The patients will receive Canagliflozin orally for 36 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time Frame
Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks
Secondary Outcome Measure Information:
Title
Change in Percentage of HbA1c
Time Frame
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Title
Change in Fasting Plasma Glucose
Time Frame
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks
Title
Percentage Change in Body Weight
Time Frame
Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kazuoki Kondo, MD
Organizational Affiliation
Mitsubishi Tanabe Pharma Corporation
Official's Role
Study Director
Facility Information:
Facility Name
Reserch site
City
Chubu
Country
Japan
Facility Name
Reserch site
City
Chugoku
Country
Japan
Facility Name
Reserch site
City
Hokkaido
Country
Japan
Facility Name
Reserch site
City
Kanto
Country
Japan
Facility Name
Reserch site
City
Kinki
Country
Japan
Facility Name
Reserch site
City
Kyushu
Country
Japan
Facility Name
Reserch site
City
Tohoku
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29110384
Citation
Inagaki N, Harashima SI, Kaku K, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Iijima H. Long-term efficacy and safety of canagliflozin in combination with insulin in Japanese patients with type 2 diabetes mellitus. Diabetes Obes Metab. 2018 Apr;20(4):812-820. doi: 10.1111/dom.13152. Epub 2017 Dec 5.
Results Reference
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Learn more about this trial

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

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