Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Intervention: Dapagliflozin; Dapagliflozin placebo
Intervention description: Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.; matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.
Intervention MeSH terms: Dapagliflozin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 72.0
Sex: All
Minimum age: 10 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: Diabetes Mellitus; Dapagliflozin; Placebo; Insulin resistance; Metabolic Diseases

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.
    

Eligibility criteria:

        Inclusion Criteria

          1. Provision of informed consent prior to any study-specific procedures

          2. Males and Females, ages 10 years of age, up to but not including 25 years of age at
             the time of randomization

          3. Previously diagnosed as having type 2 diabetes for at least 2 months by WHO/ADA
             diagnostic criteria

          4. HbA1c >= 6.5% and <= 11% obtained at screening visit

          5. Currently on diet and exercise and a stable dose of metformin (at least 1000 mg daily)
             for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a
             stable combination of metformin (at least 1000 mg daily) and insulin for a minimum of
             8 weeks prior to screening

          6. FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

        Exclusion Criteria:

          1. Previous diagnosis of Type 1 diabetes

          2. Diabetes ketoacidosis (DKA) within 6 months of screening

          3. Current use of the following medications for the treatment of diabetes, or use within
             the specified timeframe prior to screening for the main study:

               -  Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, or
                  injectable incretins or incretin mimetics or other antidiabetes medications not
                  otherwise specified

               -  Sixteen weeks: thiazolidinediones

               -  Any previous history or current use of an SGLT2 inhibitor, including
                  dapagliflozin

          4. 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

          5. Pregnant, positive serum pregnancy test, planning to become pregnant during the
             clinical trials, or breastfeeding

          6. History of unstable or rapidly progressive renal disease

          7. History of unresolved vesico-ureteral reflux

          8. 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

          9. 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)

         10. Presence of either: antibodies to glutamic acid decarboxylase (GAD) or protein
             tyrosine phosphatase-like protein antibodies (IA-2)

         11. An abnormal TSH value at screening will be further evaluated for free T4. Subjects
             with abnormal free T4 values will be excluded

         12. Hematuria (confirmed by microscopy at screening) with no explanation as judged by the
             investigator up to randomization

         13. 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

         14. 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