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
- Type 2 diabetes mellitus without complications,
- Registration Number
- CTRI/2019/08/020642
- Lead Sponsor
- AstraZeneca
- Brief Summary
The proposed study is a 26-week Phase 3b, multicenter, randomized, placebo-controlled, double-blind, parallel-group study with a 26-week safety extension period to evaluate the safety and efficacy of dapagliflozin (5 mg and 10 mg), and, separately, saxagliptin (2.5 mg and 5 mg) in pediatric subjects with T2DM with an additional post-study visit at Week 104 for assessment of measures of growth and maturity. Approximately 243 pediatric subjects globally and out of which 37 subjects from India will be randomized in a 1:1:1 ratio to receive dapagliflozin 5 mg, saxagliptin 2.5 mg, or placebo. Approximately 81 subjects will be randomized to each treatment arm.
After a 26-week, double-blind, short term treatment period, the primary efficacy endpoint (change in HbA1C from baseline to week 26 of treatment) will be assessed. This will be followed by a 26-week, site- and subject-blind long term safety extension period. Dapagliflozin and, separately, saxagliptin will be compared against the single shared placebo comparator.
Measures of growth and maturity will be assessed at the Week 104 post-study visit.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 243
- 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 placebo Change in HbA1c from baseline to week 26
- Secondary Outcome Measures
Name Time Method Change in Fasting Plasma Glucose (FPG) from baseline to Week 26 Week 26 Percentage of subjects with baseline HbA1c ≥ 7% who achieve an HbA1c level of less than 7.0% Week 26
Trial Locations
- Locations (12)
Apollo Gleneagles Hospital - Kolkata
🇮🇳Kolkata, WEST BENGAL, India
Bangalore Medical College and Research Institute (BMCRI) - Vanivilas Hospital
🇮🇳Bangalore, KARNATAKA, India
Diabetes Care & Research Centre S.P.Medical College & AG of Hospitals
🇮🇳Bikaner, RAJASTHAN, India
Government Medical College
🇮🇳Kozhikode, KERALA, India
King George Hospital
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Kovai Diabetic Speciality Centre & Hospital
🇮🇳Coimbatore, TAMIL NADU, India
Mahatma Gandhi Missions Medical College (MGM Hospital)
🇮🇳Aurangabad, MAHARASHTRA, India
Osmania General Hospital-OGH
🇮🇳Visakhapatnam, ANDHRA PRADESH, India
Poona Hospital and Research Centre
🇮🇳Pune, MAHARASHTRA, India
Postgraduate Institute of Medical Education & Research (PGIMER)
🇮🇳Chandigarh, CHANDIGARH, India
Scroll for more (2 remaining)Apollo Gleneagles Hospital - Kolkata🇮🇳Kolkata, WEST BENGAL, IndiaDr Subrata DeyPrincipal investigator9836542460sbrtdey@yahoo.com