Phase 3
Completed N=171
A Study to Investigate the Efficacy and Safety of Canagliflozin in Children and Adolescents (>=10 to <18 Years) With Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT03170518 ↗Enrolled (actual)
171
Serious AEs
7.6%
Results posted
Mar 2025
Primary outcomePrimary: Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 — 0.39; -0.37 Percent (%) of HbA1c — p== 0.002
◆ Published Evidence
Emerging
3citations · ~3 / year
Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial.
Summary
The purpose of this study is to assess the effect of canagliflozin relative to placebo on glycated hemoglobin (HbA1c) after 26 weeks of treatment, and to assess the overall safety and tolerability of canagliflozin.
Linked Publications
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Treatment With Canagliflozin Versus Placebo in Children and Adolescents With Type 2 Diabetes : A Randomized Clinical Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 26 |
0.39; -0.37 | = 0.002 sig |
| PRIMARY Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) |
74.7; 76.1; 82.4 | — |
| SECONDARY Change From Baseline in Fasting Plasma Glucose (FPG) at Weeks 26 and 52 |
15.3; -11.5; 19.2; -16.4 | — |
| SECONDARY Percentage of Participants With HbA1c Less Than (<)7.5 Percent (%), <7%, and <6.5% at Weeks 26 and 52 |
40.0; 64.9; 29.3; 69.0; 27.5; 51.9 | — |
| SECONDARY Percentage of Participants Who Received Rescue Therapy |
46.0; 11.9 | — |
| SECONDARY Time to Rescue Therapy |
21.50; 24.14 | — |
| SECONDARY Percent Change From Baseline in Body Weight at Weeks 26 and 52 |
-0.0; -1.6; 0.4; -0.5 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) at Weeks 26 and 52 |
-0.4; -0.8; -0.5; -0.7 | — |
| SECONDARY Percent Change From Baseline in Fasting Plasma Lipids Levels at Weeks 26 and 52 |
1.2; 8.2; 5.6; 5.1; 3.3; 12.4 | — |
| SECONDARY Percent Change From Baseline in LDL-C to HDL-C Ratio and Non-HDL-C to LDL-C Ratio at Weeks 26 and 52 |
0.5; 2.5; -1.5; 4.0; 1.1; 3.3 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure at Weeks 26 and 52 |
1.4; 0.7; 1.5; 0.0 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure at Weeks 26 and 52 |
-0.1; -0.1; 0.7; -0.2 | — |
| SECONDARY Change From Baseline in HbA1c at Weeks 12 and 52 |
0.10; -0.59; 0.70; -0.32 | — |
| SECONDARY Growth Velocity at Weeks 26 and 52 |
2.08; 1.94; 1.00; 1.63; 1.46; 1.76 | — |
| SECONDARY Number of Participants With Changes in Tanner Staging (Females) From Baseline at Weeks 26 and 52 |
1; 2; 1; 1; 0; 0 | — |
| SECONDARY Number of Participants With Changes in Tanner Staging (Males) From Baseline at Weeks 26 and 52 |
0; 0; 1; 0; 0; 1 | — |
| SECONDARY Change From Baseline in Bone Turnover Marker: Serum Osteocalcin and Serum Collagen Type 1 Carboxy-Telopeptide (CTx) at Weeks 26 and 52 |
-3.594; -3.328; -0.904; -8.732; -5.964; -3.475 | — |
| SECONDARY Urinary Albumin/Creatinine Ratio (ACR) at Weeks 26 and 52 |
15.62; 14.41; 24.84; 14.98; 15.45; 21.27 | — |
Eligibility 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 ( =1,000 mg per day or MTD per day for at least 8 weeks prior to screening
- 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 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)
Data sourced from ClinicalTrials.gov (NCT03170518) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.