Phase 3
Completed N=72
Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Source: ClinicalTrials.gov NCT02725593 ↗Enrolled (actual)
72
Serious AEs
6.9%
Results posted
Dec 2020
Primary outcomePrimary: Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 — -0.25; 0.50 Percentage of HbA1c — p=0.101
◆ Published Evidence
Established
84citations · ~21 / year
Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study.
Summary
A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.
Linked Publications
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Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 |
-0.25; 0.50 | 0.101 |
| SECONDARY Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 |
-0.07; 0.72 | 0.340 |
| SECONDARY Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control |
5.1; 9.1 | 0.655 |
| SECONDARY Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24 |
25.0; 4.2 | 0.056 |
Eligibility Criteria
Inclusion Criteria
- Provision of informed consent prior to any study-specific procedures
- Males and Females, ages 10 years of age, up to but not including 25 years of age at the time of randomization
- Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA diagnostic criteria
- HbA1c >= 6.5% and 4 weeks within 3 months prior to the Day 1 visit.
Note: Topical, nasal, or inhaled corticosteroids are allowed
- Abnormal renal function, which is defined in subjects = 18 years as an estimated glomerular filtration rate (eGFR) calculated by the MDRD Formula < 60 mL/min/1.73 m2 (1.33 mL/s)
- Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2)
- An abnormal TSH value at screening will be further evaluated for free T4. Subjects with abnormal free T4 values will be excluded
- Hematuria (confirmed by microscopy at screening) with no explanation as judged by the investigator up to randomization
- Anemia of any etiology defined as hemoglobin <=10.7 g/dL (107 g/L) for females and <= 11.3 g/dL (113 g/L) for males. Subjects who are considered to have anemia according to local guidelines should be excluded
- Volume-depleted subjects. Subjects at risk for volume depletion due to co-existing conditions or concomitant medications, such as loop diuretics, should carefully monitor their volume status
Data sourced from ClinicalTrials.gov (NCT02725593) 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.