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

Phase 4

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Canagliflozin (TA-7284); Drug: Placebo; Drug: Insulin

• Registration Number: NCT02220920
• Lead Sponsor: Mitsubishi Tanabe Pharma Corporation

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.

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2014-08-19
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-20
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-08
• Results First Submitted: 2016-08-03
• Results First Submitted QC: 2016-10-24
• Last Update Submitted: 2016-10-24
• Results First Posted: 2016-12-15
• Last Update Posted: 2016-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 146

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo＋insulin	Insulin	-
Canagliflozin (TA-7284) ＋insulin	Canagliflozin (TA-7284)	-
Canagliflozin (TA-7284) ＋insulin	Insulin	-
Placebo＋insulin	Placebo	-

Primary Outcome Measures

Name	Time	Method
Change in HbA1c From Baseline	baseline and Week 16

Secondary Outcome Measures

Name	Time	Method
Change in Fasting Plasma Glucose	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
Percent Change in Body Weight	baseline and Week 16

Trial Locations

Locations (1)

Reserch site; 🇯🇵 Tohoku, Japan