A clinical trial conducted in pediatric patients with Type 2 Diabetes Mellitus who are of age between 10 to 18 years to evaluate the safety and efficacy of Dapagliflozin 5 and 10 mg and Saxagliptin 2.5 and 5 mg for 26 weeks with a 26 week Safety Extension Period
- Conditions
- Health Condition 1: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2019/08/020642
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
a)Previously diagnosed with T2DM by World Health Organization/ADA criteria
b)HbA1c greater than or equal to 6.5% and less than or equal to 10.5% obtained at screening visit
c)Currently on diet and exercise and stable dose of at least 1000 mg metformin (IR or XR) for a minimum of 8 weeks, or stable dose of insulin for a minimum of 8 weeks, or a stable combination of at least 1000 mg metformin (IR or XR) and insulin for a minimum of 8 weeks prior to randomization
d)Male and female patients eligible if 10 years of age, up to but not including 18 years of age at the time of enrollment/screening. At least 30% of total subjects will be between the ages of 10 and 14 years and at least one third but no more than two thirds, female subjects.
a)Presence of Type 1 diabetes, as demonstrated by:
1. Preexisting diagnosis of Type 1 diabetes,OR
2.Positivity at screening of either antibodies to glutamic acid decarboxylase (GAD) or protein tyrosine phosphatase-like protein antibodies (IA-2) AND abnormally low levels of C-peptide. GAD and IA-2 antibody testing will be performed in all screened subjects, C-peptide only in otherwise eligible, antibody-positive subjects. All instances of antibody-positive subjects with normal or elevated C-peptide values will be discussed by the Investigator with the study med ical monitors and Sponsor’s study director to confirm study eligibility.
b)Previous diagnosis of monogenic etiology of Type 2 diabetes such as maturity onset diabetes of the young (MODY), genetic disorders with strong associations with insulin resistance/diabetes and/or obesity such as Turner’s Syndrome and Prader-Willi, or secondary diabetes (steroid use, Cushing’s disease, acromegaly), secondary diabetes mellitus, or diabetes insipidus.
c)Diabetes ketoacidosis (DKA) within 6 months of screening
d)Current use of the following medications for the treatment of diabetes, or use within the specified timeframe prior to screening for the main study:
i.Eight weeks: sulfonylureas, alpha glucosidase inhibitors, metiglinide, oral or injectable incretins or incretin mimetics, other antidiabetes medications not otherwise specified
ii.Sixteen weeks: thiazolidinediones. DPP-4 inhibitors (with no reported medication related AEs related to DPP-4 inhibitors), sodium glucose cotransporter-2 (SGLT-2) inhibitors (with no reported medication related AEs related to SGLT-2 inhibitors)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in HbA1C from baseline to week 26 after 26 weeks of double blind, add-on oral therapy of Dapagliflozin or Saxagliptin compared to placeboTimepoint: Change in HbA1c from baseline to week 26
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose (FPG) from baseline to Week 26Timepoint: Week 26;Percentage of subjects with baseline HbA1c = 7% who achieve an HbA1c level of less than 7.0%Timepoint: Week 26