NCT02597309|WithdrawnPhase 4
The Effect of add-on Canagliflozin in Patients With Type 2 Diabetes Treated With U-500 Insulin
I-Can
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I-Can
Sponsor study identifier
interventional
0
1 country
1
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
The aim of this study is to evaluate the effect of adding a SGLT-2 inhibitor (namely Canagliflozin) on the dose of U-500 insulin required to achieve glycemic control in patients with type 2 diabetes. We hypothesize that adding Canagliflozin to patients treated with U-500 insulin may result in significant reduction in insulin dose due to improved insulin sensitivity and weight loss.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
November 3, 2015
Actual (reported)November 5, 2015
Actual (reported)July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Reduction in insulin recuirement
Reduction in insulin requirements after adding canagliflozin with a difference in insulin dose of ≥30% between the 2 intervention groups
Twenty four weeks
Subjects in this group will take canagliflozin in addition to their regular U-500 insulin dose and other antihyperglycemic medications. Canagliflozin dose will be titrated after 2 weeks from 100 mg once daily to 300 mg once daily. This dose will continue for 22 weeks.
Subjects in this group will take a matched placebo in addition to their regular U-500 insulin dose and other antihyperglycemic medications for 2 weeks then another matched-placebo for 22 weeks.
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Joslin Diabetes Center
Boston, Massachusetts, 02215, United States
0 participants (actual enrollment reported by the registry).
First Submitted
November 3, 2015
First Posted
November 5, 2015
Study Start
November 2015
Date type not reportedThis date has not been verified as actual or estimated.
Role of Canagliflozin on CD34+ Cells in Patients With Type 2 Diabetes
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Primary Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
July 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 1, 2017
Record last verified: 2017-02
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Source: ClinicalTrials.gov.
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