---
title: Efficacy and Safety Study of Canagliflozin (TA-7284) in Combination With Insulin in Patients With Type 2 Diabetes Mellitus
nct_id: NCT02220920
overall_status: COMPLETED
phase: PHASE4
sponsor: Tanabe Pharma Corporation
study_type: INTERVENTIONAL
primary_condition: Type 2 Diabetes Mellitus
countries: Japan
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02220920.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02220920"
ct_last_update_post_date: 2026-01-08
last_seen_at: "2026-05-12T06:56:13.885Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# 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

**NCT ID:** [NCT02220920](https://clinicaltrials.gov/study/NCT02220920)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 146
- **Lead Sponsor:** Tanabe Pharma Corporation
- **Conditions:** Type 2 Diabetes Mellitus
- **Start Date:** 2014-08
- **Completion Date:** 2015-07
- **CT.gov Last Update:** 2026-01-08

## 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.

## Eligibility

- **Minimum age:** 20 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Canagliflozin (TA-7284) ＋insulin** (EXPERIMENTAL)
- **Placebo＋insulin** (PLACEBO_COMPARATOR)

## Interventions

- **Canagliflozin (TA-7284)** (DRUG) — The patients will receive Canagliflozin orally for 16 weeks
- **Placebo** (DRUG) — The patients will receive Placebo orally for 16 weeks
- **Insulin** (DRUG)

## Primary Outcomes

- **Change in HbA1c From Baseline** _(time frame: baseline and Week 16)_

## Secondary Outcomes

- **Change in Fasting Plasma Glucose** _(time frame: baseline and Week 16)_
- **Percent Change in Body Weight** _(time frame: baseline and Week 16)_
- **Change in Blood Pressure** _(time frame: baseline and Week 16)_
- **Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased"** _(time frame: Week 16)_

## Locations (7)

- Reserch site, 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

## Recent Field Changes (last 30 days)

- `locations.reserch site|chūbu||japan` — added _(2026-05-12)_
- `locations.reserch site|hokkaido||japan` — added _(2026-05-12)_
- `locations.reserch site|kanto||japan` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.reserch site|chugoku||japan` — added _(2026-05-12)_
- `locations.reserch site|kinki||japan` — added _(2026-05-12)_
- `locations.reserch site|kyushu||japan` — added _(2026-05-12)_
- `locations.reserch site|tōhoku||japan` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT02220920.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT02220920*  
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