Health Condition 1: E119- Type 2 diabetes mellitus without complications
Conditions
Interventions
Intervention1: Dapagliflozin: Dapagliflozin is a rationally designed, stable, competitive, reversible, highly selective and orally active inhibitor of SGLT-2, the major transporter responsible for ren
Sponsors
AstraZeneca
Pharmaceutical Research Associates India Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Finland, India, Italy, Malaysia, Mexico, New Zealand, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Taiwan, Thailand, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactJigar Lakhani
Pharmaceutical Research Associates India Pvt. Ltd
Outcome results
None listed