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

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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Insulin; Drug: Canagliflozin (TA-7284); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 146
• Phase: Phase 4

Contacts and Locations

Study Locations

• Japan
  • Chugoku, Japan
    • Reserch site
  • Chūbu, Japan
    • Reserch site
  • Hokkaido, Japan
    • Reserch site
  • Kanto, Japan
    • Reserch site
  • Kinki, Japan
    • Reserch site
  • Kyushu, Japan
    • Reserch site
  • Tōhoku, Japan
    • Reserch site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

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 16 weeks
Placebo Comparator: Placebo＋insulin	Drug: Insulin; Drug: Placebo; The patients will receive Placebo orally for 16 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in HbA1c From Baseline	baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Fasting Plasma Glucose	baseline and Week 16
Percent Change in Body Weight	baseline and Week 16
Change in Blood Pressure	baseline and Week 16
Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"	Week 16

Collaborators and Investigators

• Sponsor: Tanabe Pharma Corporation
• Investigators: Study Director: Kazuoki Kondo, MD, Tanabe Pharma Corporation

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2014
• Primary Completion (Actual): July 1, 2015
• Study Completion (Actual): July 1, 2015

Study Registration Dates

• First Submitted: August 19, 2014
• First Submitted That Met QC Criteria: August 19, 2014
• First Posted (Estimated): August 20, 2014

Study Record Updates

• Last Update Posted (Estimated): January 8, 2026
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: insulin resistance
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperinsulinism; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Insulin Resistance; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptide Hormones; Peptides; Amino Acids, Peptides, and Proteins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbohydrates; Glucosides; Glycosides; Insulins; Pancreatic Hormones; Thiophenes; Proinsulin; Canagliflozin; Insulin
• Other Study ID Numbers: TA-7284-11