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About
A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.
Full description
A 24 Week, Multicenter, Randomized, Double-Blind, Parallel Group, Phase 3 Trial with a 28 Week Long Term Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 10 mg in T2DM Patients aged 10-24 years
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria:
Previous diagnosis of Type 1 diabetes
Diabetes ketoacidosis (DKA) within 6 months of screening
Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
Initiation or discontinuation of prescription or non-prescription weight loss drugs within 8 weeks of screening.
Use of prescription or non-prescription weight loss drugs must be stable during the study
Pregnant, positive serum pregnancy test, planning to become pregnant during the clinical trials, or breastfeeding
History of unstable or rapidly progressive renal disease
History of unresolved vesico-ureteral reflux
Replacement or chronic systemic corticosteroid therapy, defined as any dose of systemic corticosteroid taken for > 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 of age as an estimated glomerular filtration rate (eGFR) calculated by the Schwartz Formula < 80 mL/min/1.73 m2 (1.33 mL/s), and 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
Primary purpose
Allocation
Interventional model
Masking
72 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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