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Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue 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)
GLP-1 analogue
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 who has been receiving a stable dose and regimen of GLP-1 analogue 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 ≥7.0% 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 requiring insulin therapy
  • Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Sites / Locations

  • Reserch site
  • Reserch site
  • Reserch site
  • Reserch site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Canagliflozin (TA-7284) ＋GLP-1 analogue

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
Change in Blood Pressure

Full Information

First Posted
August 26, 2014
Last Updated
April 2, 2019
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02227849
Brief Title
Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue 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 GLP-1 Analogue 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
August 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 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
The purpose of this study is to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with GLP-1 analogue in patients with type 2 Diabetes for 52 weeks.
Detailed Description
This is an open-label study to evaluate the long-term safety and efficacy of Canagliflozin (TA-7284) in Japanese patients with type 2 diabetes mellitus, who are receiving treatment with GLP-1 analogue on diet and exercise and have inadequate glycemic control. The patients will receive TA-7284 100mg orally for 52 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
71 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin (TA-7284) ＋GLP-1 analogue
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Canagliflozin (TA-7284)
Intervention Description
The patients will receive Canagliflozin orally for 52 weeks
Intervention Type
Drug
Intervention Name(s)
GLP-1 analogue
Primary Outcome Measure Information:
Title
Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)
Time Frame
52 Weeks
Secondary Outcome Measure Information:
Title
Change in Percentage of HbA1c
Time Frame
Baseline, 52 Weeks
Title
Change in Fasting Plasma Glucose
Time Frame
Baseline, 52 Weeks
Title
Percentage Change in Body Weight
Time Frame
Baseline, 52 Weeks
Title
Change in Blood Pressure
Time Frame
Baseline, 52 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who has been receiving a stable dose and regimen of GLP-1 analogue 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 ≥7.0% 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 requiring insulin therapy 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
Nobuya Inagaki, Professor
Organizational Affiliation
Kyoto University, Graduate School of Medicine
Official's Role
Study Director
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
Hokkaido
Country
Japan
Facility Name
Reserch site
City
Kanto
Country
Japan
Facility Name
Reserch site
City
Kinki
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
29473709
Citation
Harashima SI, Inagaki N, Kondo K, Maruyama N, Otsuka M, Kawaguchi Y, Watanabe Y. Efficacy and safety of canagliflozin as add-on therapy to a glucagon-like peptide-1 receptor agonist in Japanese patients with type 2 diabetes mellitus: A 52-week, open-label, phase IV study. Diabetes Obes Metab. 2018 Jul;20(7):1770-1775. doi: 10.1111/dom.13267. Epub 2018 Mar 24.
Results Reference
result

Learn more about this trial

Long-Term Safety Study of Canagliflozin (TA-7284) in Combination With GLP-1 Analogue in Patients With Type 2 Diabetes Mellitus

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