Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
NCT ID: NCT02725593
Last Updated: 2022-02-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
72 participants
INTERVENTIONAL
2016-06-22
2020-04-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Dapagliflozin
Dapagliflozin
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.
Dapagliflozin placebo
Dapagliflozin placebo
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.
Interventions
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Dapagliflozin
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.
Dapagliflozin placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
10 Years
24 Years
ALL
No
Sponsors
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Parexel
INDUSTRY
Q2 Solutions
INDUSTRY
PRA Health Sciences
INDUSTRY
Covance
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Locations
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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
Research Site
México, D.F., , Mexico
Research Site
Monterrey, , Mexico
Research Site
Zapopan, , Mexico
Research Site
Oradea, , Romania
Research Site
Timișoara, , Romania
Research Site
Izhevsk, , Russia
Research Site
Krasnoyarsk, , Russia
Research Site
Moscow, , Russia
Research Site
Novosibirsk, , Russia
Research Site
Pyatigorsk, , Russia
Research Site
Rostov-on-Don, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Samara, , Russia
Research Site
Saratov, , Russia
Research Site
Tomsk, , Russia
Research Site
Kent, , United Kingdom
Research Site
Leicester, , United Kingdom
Countries
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References
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Tamborlane WV, Laffel LM, Shehadeh N, Isganaitis E, Van Name M, Ratnayake J, Karlsson C, Norjavaara E. Efficacy and safety of dapagliflozin in children and young adults with type 2 diabetes: a prospective, multicentre, randomised, parallel group, phase 3 study. Lancet Diabetes Endocrinol. 2022 May;10(5):341-350. doi: 10.1016/S2213-8587(22)00052-3. Epub 2022 Apr 1.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2015-005041-31
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D1690C00017
Identifier Type: -
Identifier Source: org_study_id
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