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Efficacy and 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)
Placebo
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 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

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Canagliflozin (TA-7284) ＋insulin

Placebo＋insulin

Arm Description

Outcomes

Primary Outcome Measures

Change in HbA1c From Baseline

Secondary Outcome Measures

Change in Fasting Plasma Glucose
Percent Change in Body Weight
Change in Blood Pressure
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"

Full Information

First Posted
August 19, 2014
Last Updated
October 24, 2016
Sponsor
Mitsubishi Tanabe Pharma Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02220920
Brief Title
Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
August 2014 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (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 efficacy and safety of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes for 16 weeks administration.
Detailed 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.

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
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Canagliflozin (TA-7284) ＋insulin
Arm Type
Experimental
Arm Title
Placebo＋insulin
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Canagliflozin (TA-7284)
Intervention Description
The patients will receive Canagliflozin orally for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
The patients will receive Placebo orally for 16 weeks
Intervention Type
Drug
Intervention Name(s)
Insulin
Primary Outcome Measure Information:
Title
Change in HbA1c From Baseline
Time Frame
baseline and Week 16
Secondary Outcome Measure Information:
Title
Change in Fasting Plasma Glucose
Time Frame
baseline and Week 16
Title
Percent Change in Body Weight
Time Frame
baseline and Week 16
Title
Change in Blood Pressure
Time Frame
baseline and Week 16
Title
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"
Time Frame
Week 16

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 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
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
27316668
Citation
Inagaki N, Harashima S, Maruyama N, Kawaguchi Y, Goda M, Iijima H. Efficacy and safety of canagliflozin in combination with insulin: a double-blind, randomized, placebo-controlled study in Japanese patients with type 2 diabetes mellitus. Cardiovasc Diabetol. 2016 Jun 18;15:89. doi: 10.1186/s12933-016-0407-4.
Results Reference
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Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus

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