A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus

• Register: ClinicalTrials.gov
• Last refreshed on: 20 November 2023
• Main ID: NCT03170518
• Date of registration: 26/05/2017
• Prospective Registration: Yes
• Primary sponsor: Janssen Research & Development, LLC
• Public title: A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
• Scientific title: A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (=10 to <18 Years) With Type 2 Diabetes Mellitus
• Date of first enrolment: July 21, 2017
• Target sample size: 171
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03170518
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Brazil, China, Greece, India, Israel, Malaysia, Mexico, Philippines, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Janssen Research & Development, LLC Clinical Trial
• Affiliation: Janssen Research & Development, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

- Participants with a diagnosis of type 2 diabetes mellitus (T2DM)

- Random C-peptide at screening greater than (>)0.6 nanogram/milliliter (ng/mL) (>0.2
nanomole/liter [nmol]/L])

- HbA1c of greater than or equal to (>=)6.5 percent (%) to less than or equal to
(<=)11.0% and meets 1 of the inclusion criteria below:

1. On diet and exercise only for at least 4 weeks prior to screening

2. On diet and exercise and a stable dose of metformin monotherapy >=1,000 mg per
day or MTD per day for at least 8 weeks prior to screening

3. On diet and exercise and a stable insulin monotherapy regimen for at least 8
weeks prior to screening (stable dose is defined as no change in the insulin
regimen [that is, type{s} of insulin] and <=15% change in the total daily dose of
insulin [averaged over 1 week to account for day to day variability])

4. On diet and exercise and a stable combination therapy with metformin and insulin
for at least 8 weeks prior to screening

Exclusion Criteria:

- History of diabetic ketoacidosis (DKA), type 1 diabetes mellitus (T1DM), pancreas or
cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy or
maturity onset diabetes of the young (MODY)

- Participants on any antihyperglycemic agents (AHAs) other than metformin, or
injectable insulin within 8 weeks of the first dose of study drug (that is Day 1)

- Repeated (2 or more over a 1-week period) fasting self-monitoring of blood glucose
(SMBG) measurements >270 milligram/deciliter (mg/dL) (>15 millimole/liter [mmol/L])
during the pretreatment phase, despite reinforcement of diet and exercise counseling

- Severe hypoglycemia within 6 months prior to Day 1

- History of hereditary glucose-galactose malabsorption or primary renal glucosuria

- Alanine aminotransferase level >5.0 times the upper limit of normal (ULN) or total
bilirubin >1.5 times the ULN at screening (for elevations in bilirubin: if, in the
opinion of the investigator and agreed upon by the sponsor's medical officer, the
elevation in bilirubin is consistent with Gilbert's disease, the subject may
participate)



Age minimum: 10 Years
Age maximum: 17 Years
Gender: All

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: Placebo

Drug: Canagliflozin 300 mg

Drug: Canagliflozin 100 mg

Primary Outcome(s)

Percentage of Participants with Adverse Events as a Measure of Safety and Tolerability [Time Frame: Up to Week 56]

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 26 [Time Frame: Baseline, up to Week 26]

Secondary Outcome(s)

Change in Fasting Plasma Glucose (FPG) From Baseline at Week 26 and Week 52 [Time Frame: Baseline (Day 1), Week 26, and Week 52]

Time to Rescue Therapy [Time Frame: Baseline (Day 1) up to Week 26 and Week 52]

Change in Glycated Hemoglobin (HbA1c) From Baseline at Week 52 [Time Frame: Baseline, up to Week 52]

Percent Change in Body Weight From Baseline at Week 26 and Week 52 [Time Frame: Baseline (Day 1), Week 26 and Week 52]

Proportion of Participants With HbA1c <6.5% at Week 26 and Week 52 [Time Frame: Week 26 and Week 52]

Proportion of Participants who will Receive Rescue Therapy [Time Frame: Week 26 and Week 52]

Proportion of Participants With HbA1c <7.0% at Week 26 and Week 52 [Time Frame: Week 26 and Week 52]

Proportion of Participants With HbA1c less than (<)7.5 percent (%) at Week 26 and Week 52 [Time Frame: Week 26 and Week 52]

Secondary ID(s)

CR108298

2016-005223-88

28431754DIA3018

Source(s) of Monetary Support

Please refer to primary and secondary sponsors