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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02220920
Recruitment Status : Completed
First Posted : August 20, 2014
Results First Posted : December 15, 2016
Last Update Posted : December 15, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Canagliflozin (TA-7284) Drug: Placebo Drug: Insulin Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : August 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : July 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Canagliflozin (TA-7284) +insulin Drug: Canagliflozin (TA-7284)
The patients will receive Canagliflozin orally for 16 weeks

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

Drug: Insulin



Primary Outcome Measures :
  1. Change in HbA1c From Baseline [ Time Frame: baseline and Week 16 ]

Secondary Outcome Measures :
  1. Change in Fasting Plasma Glucose [ Time Frame: baseline and Week 16 ]
  2. Percent Change in Body Weight [ Time Frame: baseline and Week 16 ]
  3. Change in Blood Pressure [ Time Frame: baseline and Week 16 ]
  4. Percentage of Participants With "Adverse Events" and "Hypoglycemia and Blood Glucose Decreased" [ Time Frame: Week 16 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02220920


Locations
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Japan
Reserch site
Chubu, Japan
Reserch site
Chugoku, Japan
Reserch site
Hokkaido, Japan
Reserch site
Kanto, Japan
Reserch site
Kinki, Japan
Reserch site
Kyushu, Japan
Reserch site
Tohoku, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
Investigators
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Study Director: Kazuoki Kondo, MD Mitsubishi Tanabe Pharma Corporation
Publications of Results:
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Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT02220920    
Other Study ID Numbers: TA-7284-11
First Posted: August 20, 2014    Key Record Dates
Results First Posted: December 15, 2016
Last Update Posted: December 15, 2016
Last Verified: August 2016
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
insulin resistance
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Canagliflozin
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action