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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02725593
• Date of registration: 29/03/2016
• Prospective Registration: Yes
• Primary sponsor: AstraZeneca
• Public title: Study to Evaluate Safety and Efficacy of Dapagliflozin in Patients With Type 2 Diabetes Mellitus Aged 10-24 Years
• Scientific title: 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
• Date of first enrolment: June 22, 2016
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02725593
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Hungary, Israel, Mexico, Romania, Russian Federation, Spain, United Kingdom, United States

Key inclusion & exclusion 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



Age minimum: 10 Years
Age maximum: 24 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes

Intervention(s)

Drug: Dapagliflozin

Drug: Dapagliflozin placebo

Primary Outcome(s)

Adjusted Change From Baseline in Glycated Haemoglobin (HbA1c) at Week 24 [Time Frame: Baseline to Week 24]

Secondary Outcome(s)

Percentage of Participants With Baseline Glycated Haemoglobin (HbA1c) >= 7% Who Achieved HbA1c Level < 7% at Week 24 [Time Frame: Baseline to Week 24]

Adjusted Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 [Time Frame: Baseline to Week 24]

Percentage of Participants Who Required Glycemic Rescue Medication or Permanently Discontinued Treatment Due to Lack of Glycemic Control [Time Frame: Baseline to Week 24]

Secondary ID(s)

D1690C00017

2015-005041-31

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Parexel

Covance Laboratories, Inc

PRA Health Sciences

Q2 Solutions

Results

• Results available: Yes
• Date Posted: 02/12/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02725593