A Study of Effects of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Participants With Type 1 Diabetes Mellitus (T1DM)
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|ClinicalTrials.gov Identifier: NCT02139943|
Recruitment Status : Completed
First Posted : May 16, 2014
Results First Posted : July 18, 2016
Last Update Posted : July 18, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 1||Drug: Canagliflozin 100 mg Drug: Canagliflozin 300 mg Drug: Placebo||Phase 2|
This is a randomized (the study medication is assigned by chance), double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled (an inactive substance that is compared with a medication to test whether the medication has a real effect) parallel-group, multicenter study of canagliflozin as an addition to insulin therapy for participants with type 1 diabetes mellitus and inadequate glycemic control.
Approximately 330 participants will be randomly assigned in a 1:1:1 ratio to either canagliflozin 100 mg, canagliflozin 300 mg, or placebo groups. About 90 participants (30 per treatment group) will be selected for a substudy with a purpose of a continuous glucose monitoring (CGM) assessment for 7 days at baseline and 7 days at the end of treatment.
The total duration of the participation will be about 22 weeks, during which participants will need to return to investigational sites for approximately 9 visits. During the study participants will receive advice on treatment of hypoglycemia and diabetic ketoacidosis (DKA), as well as on compliance with diet and exercise.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||352 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized Phase 2, Double-blind, Placebo-controlled, Treat-to-Target, Parallel-group, 3-arm, Multicenter Study to Assess the Efficacy and Safety of Canagliflozin as Add-on Therapy to Insulin in the Treatment of Subjects With Type 1 Diabetes Mellitus|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||June 2015|
Experimental: Canagliflozin 100 mg
Each participant will receive 100 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 100 mg
Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
Experimental: Canagliflozin 300 mg
Each participant will receive 300 mg of canagliflozin once daily for 18 weeks.
Drug: Canagliflozin 300 mg
Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
Placebo Comparator: Placebo
Each participant will receive matching placebo once daily for 18 weeks
Matching placebo capsule will be taken orally, before the first meal of the day.
- Percentage of Participants With Hemoglobin A1c (HbA1c) Reduction Greater Than or Equal to (>=) 0.4 Percent (%) and no Increase in Body Weight [ Time Frame: Week 18 ]Clinical response at Weeks 18 was assessed by the percentage of participants with Hemoglobin A1c (HbA1c) reduction greater than or equal to 0.4 % and had no increase in body weight.
- Percentage of Participants With Adverse Events [ Time Frame: Up to 22 Weeks ]
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): NCT02139943
|Study Director:||Janssen Research & Development, LLC Clinical Trial||Janssen Research & Development, LLC|