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

NCT ID: NCT02220920

Last Updated: 2016-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Type 2 Diabetes Mellitus

Keywords

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insulin resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Canagliflozin (TA-7284) ＋insulin

Group Type EXPERIMENTAL

Canagliflozin (TA-7284)

Intervention Type DRUG

The patients will receive Canagliflozin orally for 16 weeks

Insulin

Intervention Type DRUG

Placebo＋insulin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

The patients will receive Placebo orally for 16 weeks

Insulin

Intervention Type DRUG

Interventions

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Canagliflozin (TA-7284)

The patients will receive Canagliflozin orally for 16 weeks

Intervention Type DRUG

Placebo

The patients will receive Placebo orally for 16 weeks

Intervention Type DRUG

Insulin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mitsubishi Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kazuoki Kondo, MD

Role: STUDY_DIRECTOR

Mitsubishi Tanabe Pharma Corporation

Locations

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Reserch site

Chugoku, , Japan

Site Status

Reserch site

Chūbu, , Japan

Site Status

Reserch site

Hokkaido, , Japan

Site Status

Reserch site

Kanto, , Japan

Site Status

Reserch site

Kinki, , Japan

Site Status

Reserch site

Kyushu, , Japan

Site Status

Reserch site

Tōhoku, , Japan

Site Status

Countries

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Japan

References

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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.

Reference Type RESULT
PMID: 27316668 (View on PubMed)

Other Identifiers

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TA-7284-11

Identifier Type: -

Identifier Source: org_study_id