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Sodium-glucose cotransporter 2 (SGLT2) inhibitor

Canagliflozin 100 mg for Type 2 Diabetes

Phase 3
Waitlist Available
Research Sponsored by Janssen Research & Development, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (day 1), week 26 and week 52
Awards & highlights

Study Summary

This trial is testing whether the drug canagliflozin can help control blood sugar levels in people with type 2 diabetes. It also assesses the safety and side effects of the drug.

Eligible Conditions
  • Type 2 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (day 1), week 26 and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (day 1), week 26 and week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26
Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability
Secondary outcome measures
Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52
Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52
Percent Change in Body Weight From Baseline at Week 26 and Week 52
+5 more
Other outcome measures
Change in Body Mass Index (BMI) From Baseline at Week 26 and Week 52
Change in Bone Turnover Marker: Serum Collagen Type 1 Carboxy-Telopeptide (CTx) From Baseline at Week 26 and Week 52
Change in Bone Turnover Marker: Serum Osteocalcin From Baseline at Week 26 and Week 52
+8 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single-blind run-in Period: PlaceboExperimental Treatment1 Intervention
Participants will receive 1 placebo tablet matching canagliflozin 100 milligram (mg) once-daily during the 2-week single-blind placebo run-in period.
Group II: Double-blind Treatment Phase: Canagliflozin or PlaceboExperimental Treatment3 Interventions
Canagliflozin 100 mg/matching placebo once-daily during first 12 weeks. At Week 13, participants who have glycated hemoglobin (HbA1c) of greater than or equal to (>=)7.0 percent (%), estimated glomerular filtration rate (eGFR) >=60 milliliter/minute/1.73 meter square (mL/min/1.73 m^2) will be re-randomized to either remain on canagliflozin 100 mg/matching placebo or up-titrate to canagliflozin 300 mg/matching placebo till Week 52.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Canagliflozin 100 mg
2017
Completed Phase 3
~3030
Canagliflozin 300 mg
2017
Completed Phase 4
~3520
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

Janssen Research & Development, LLCLead Sponsor
975 Previous Clinical Trials
6,384,137 Total Patients Enrolled
Janssen Research & Development, LLC Clinical TrialStudy DirectorJanssen Research & Development, LLC
745 Previous Clinical Trials
3,959,734 Total Patients Enrolled

Media Library

Canagliflozin 100 mg (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03170518 — Phase 3
Type 2 Diabetes Research Study Groups: Single-blind run-in Period: Placebo, Double-blind Treatment Phase: Canagliflozin or Placebo
Type 2 Diabetes Clinical Trial 2023: Canagliflozin 100 mg Highlights & Side Effects. Trial Name: NCT03170518 — Phase 3
Canagliflozin 100 mg (Sodium-glucose cotransporter 2 (SGLT2) inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03170518 — Phase 3
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT03170518 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For what purpose is Canagliflozin 300 mg generally taken?

"Canagliflozin 300 mg can be used to manage major adverse cardiac events, diet, and albuminuria."

Answered by AI

Does my health profile fit the requirements for this clinical trial?

"Children and adolescents between the ages of 10 and 17 who have type 2 diabetes mellitus are eligible to participate in this clinical trial. A total of 171 patients are needed for the study."

Answered by AI

Are there precedent studies to this proposed 300 mg Canagliflozin dosage?

"The first clinical trial studying canagliflozin 300 mg was completed in 2016 at Atlanta VA Medical Center. To date, a total of 18329 clinical trials have been completed. Currently, there are 9 ongoing studies, with a large concentration being performed in Aurora, Colorado."

Answered by AI

Have these findings been published before?

"Since 2016, Canagliflozin 300 mg has been under clinical observation. In 2016, Janssen Scientific Affairs, LLC ran the first clinical trial. 40 participants were involved. After Phase 4 approval was given, 9 more studies commenced in 105 different cities and 12 countries."

Answered by AI

In how many distinct areas is this clinical trial taking place?

"The trial is currently being conducted at the University of Colorado School of Medicine/Children's Hospital Colorado in Aurora, Colorado, Center of Excellence for Diabetes and Endocrinology (CEDE) in Sacramento, California, and Columbus Clinical Services LLC in Miami, Florida with an additional 14 sites."

Answered by AI

Does this research include individuals aged 50 or older?

"This particular trial is only enrolling patients who are between 10-17 years old."

Answered by AI

What are the FDA's current thoughts on Canagliflozin 300 mg?

"Canagliflozin 300 mg is in Phase 3 of clinical trials, meaning that it has received some support for efficacy and multiple rounds of support for safety. Our team at Power has estimated the safety to be a 3 on a scale from 1 to 3."

Answered by AI

Are there any remaining openings for patients who want to enroll in this research?

"No, this particular trial is not actively seeking patients at the moment according to the clinicaltrials.gov website. This trial was first posted on July 21st, 2017 and was last edited on November 8th, 2022. However, there are other 1462 trials that are looking for patients right now."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
California
Florida
How old are they?
65+
What site did they apply to?
Center of Excellence for Diabetes and Endocrinology (CEDE)
University of Iowa Hospitals and Clinics
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I’m interested in this this study because wants to try different medications for my diabetes the ones the doctor prescribed for me it’s not working I have stop taking them hope the study will help lower my A1C.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
2017. "A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03170518.
~22 spots leftby Apr 2025
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