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

NCT02220920 | Completed Phase 4 Results

• 1 other identifier: TA-7284-11
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 7

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c From Baseline

  baseline and Week 16

Secondary Outcomes (4)

• 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

Study Arms (2)

Canagliflozin (TA-7284) ＋insulin

EXPERIMENTAL

Drug: Canagliflozin (TA-7284); Drug: Insulin

Placebo＋insulin

PLACEBO COMPARATOR

Drug: Placebo; Drug: Insulin

Interventions

Canagliflozin (TA-7284) DRUG

The patients will receive Canagliflozin orally for 16 weeks

Canagliflozin (TA-7284) ＋insulin

Placebo DRUG

The patients will receive Placebo orally for 16 weeks

Placebo＋insulin

Insulin DRUG

Canagliflozin (TA-7284) ＋insulin; Placebo＋insulin

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tanabe Pharma Corporation: lead

Study Sites (7)

Reserch site

Chugoku, Japan

Location

Reserch site

Chūbu, Japan

Location

Reserch site

Hokkaido, Japan

Location

Reserch site

Kanto, Japan

Location

Reserch site

Kinki, Japan

Location

Reserch site

Kyushu, Japan

Location

Reserch site

Tōhoku, Japan

Location

Related Publications (1)

• 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.

  PMID: 27316668 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Insulin Resistance

Interventions

Canagliflozin; Insulin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glucosides; Glycosides; Carbohydrates; Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Clinical Trials, Information Desk
• Organization: Tanabe Pharma Corporation

cti-inq-ml.JP@ml.tanabe-pharma.com

Study Officials

• Kazuoki Kondo, MD

  Tanabe Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2014
• First Posted: August 20, 2014
• Study Start: August 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: January 8, 2026
• Results First Posted: December 15, 2016

Record last verified: 2025-12

Locations

JP (7)