Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 2 Diabetes

In brief

A trial of patients aged 10-24 years with type 2 diabetes mellitus to evaluate the comparative efficacy and safety between dapagliflozin and Placebo.

Key facts

Study ID

NCT02725593

Run by

AstraZeneca

People needed

72

Starts

2016-06-22

Expected to finish

2020-04-06

Last updated by the study team

2022-02-23

Who can join

Age: 10 and older, up to 24. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 <= 11% obtained at screening visit
• 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
• FPG <=255 mg/dL (<= 14.2 mmol/L) obtained at screening visit

You may not qualify if…

• 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:
• 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
• 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

Where it is running

• Research Site — New Haven, Connecticut, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Homestead, Florida, United States
• Research Site — Miami, Florida, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Buffalo, New York, United States
• Research Site — The Bronx, New York, United States
• Research Site — Columbus, Ohio, United States
• Research Site — Philadelphia, Pennsylvania, United States
• Research Site — Greenville, South Carolina, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Memphis, Tennessee, United States
• Research Site — Lampasas, Texas, United States
• Research Site — McAllen, Texas, United States
• Research Site — Budapest, Hungary
• Research Site — Nyíregyháza, Hungary
• Research Site — Beersheba, Israel
• Research Site — Haifa, Israel
• Research Site — Jerusalem, Israel
• Research Site — Ramat Gan, Israel
• Research Site — Ẕerifin, Israel
• Research Site — Culiacán, Mexico
• Research Site — Guadalajara, Mexico
• Research Site — Mérida, Mexico

Full record on ClinicalTrials.gov

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