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NCT Number: NCT02622113

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

This extension study was designed to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with Insulin in patients with type 2 Diabetes Mellitus. The extension study was an extension to double-blind study of 16 weeks (TA-7284-11)

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Reserch site, Chugoku, Japan

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About this study

This is an open-label extension study to evaluate the safety and efficacy of Canagliflozin (TA-7284) in combination with insulin in Japanese patients with Type 2 diabetes mellitus, who are not optimally controlled on diet and exercise. The patients will enroll from the double-blind study of 16 weeks and receive TA-7284 100mg orally for 36 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients should complete the week 16 assessments in the double-blind study (TA-7284-11)

Exclusion criteria

  • Patients with hereditary glucose-galactose malabsorption or primary renal glucosuria
  • Patients with severe diabetic complications (proliferative diabetic retinopathy, stage 4 nephropathy, or serious diabetic neuropathy)
  • Patients with serious renal or hepatic disease
  • Patients who are the excessive alcohol addicts
  • Patients who are pregnant, lactating and probably pregnant patients and patients who can not agree to contraception

Treatment and study plan

Canagliflozin (TA-7284)

Drug

The patients will receive Canagliflozin orally for 36 weeks

Insulin

Drug

Primary outcomes

  1. Safety and Tolerability Assessed by Adverse Events (Number of Participants Experiencing With Adverse Events)

    Time frame: Placebo/CANA: 36 Weeks, CANA/CANA: 52 Weeks

Secondary outcomes

  1. Change in Percentage of HbA1c

    Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

  2. Change in Fasting Plasma Glucose

    Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

  3. Percentage Change in Body Weight

    Time frame: Placebo/CANA: Baseline, 36 Weeks; CANA/CANA: Baseline, 52 Weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

An Open-Label, Multicenter Study to Evaluate the Long-Term Safety, Tolerability and Efficacy of Canagliflozin (TA-7284) as add-on to Insulin in Subjects With Type 2 Diabetes Mellitus

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Dec 4, 2015
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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