Type 2 diabetes MedDRA version: 20.0 Level: HLT Classification code 10012602 Term: Diabetes mellitus (incl subtypes) System Organ Class: 100000004860
Conditions
Interventions
Trade Name: BYDUREON (2 mg powder and solvent for prolonged-release suspension for injection)
Product Name: Exenatide
Pharmaceutical Form: Powder and solvent for suspension for injection in pre-filled
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Each patient must meet the following criteria to be enrolled in this study. 1. Is a child or an adolescent of 10 to 0.6 ng/mL at Visit 1 (Screening) 5. Has been treated with diet and exercise alone or in combination with a stable dose of an oral antidiabetic agent (e.g., metformin and/or SU) and/or insulin for their type 2 diabetes for at least 2 months prior to Visit 1 (Screening) 6. Has a fasting plasma glucose concentration =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from the study. 1. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the Investigator, including but not limited to the following conditions: a. Hepatic disease (defined by aspartate or alanine transaminase >3.0 times the upper limit of normal (ULN), b. Renal disease or serum creatinine >1.5 mg/dL (132.6 µmol/L) (males) or 1.4 mg/dL (123.8 µmol/L) (females), c. Gastrointestinal disease deemed significant by the Investigator, d. Organ transplantation, e. Chronic infection (e.g., tuberculosis, human immunodeficiency virus, hepatitis B virus, or hepatitis C virus), f. Clinically significant malignant disease (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening) 2. Has positive antibody titers to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512) at Visit 1 (Screening) 3. Has a personal or family history of elevated calcitonin, calcitonin >100 ng/L, medullary thyroid carcinoma, or multiple endocrine neoplasia-2 4. Has ever used exenatide (exenatide once weekly [exenatide LAR], exenatide BID, BYETTA, or any other formulation) or any glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., liraglutide [Victoza®]) 5. Is pregnant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the effect on glycemic control, as measured by glycosylated hemoglobin (HbA1c), of exenatide once weekly (EQW) following 24 weeks of treatment compared to placebo in children and adolescents with type 2 diabetes mellitus To evaluate the safety and tolerability of EQW compared to placebo following 24 weeks of treatment in children and adolescents with type 2 diabetes mellitus;Secondary Objective: To compare the effects of EQW following 24 weeks of treatment to those achieved by placebo in children and adolescents with T2D on the following: Fasting plasma glucose concentration, Proportion of patients achieving HbA1c goals, Body weight and Tanner pubertal stage, Blood pressure and lipids To assess the effects of long-term EQW therapy (~1 year) in children and adolescents with T2D on the following: Long-term safety and tolerability, Parameters related to glycemic control, including HbA1c, fasting plasma glucose concentration, and proportion of patients achieving HbA1c goals, Body weight and Tanner pubertal stage, Blood pressure and lipids To examine the effect of exenatide once weekly on beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as measured by the homeostatic model assessment (HOMA) in children and adolescents with T2D who are not taking insulin Assess pk of exenatide once weekly in children and adolescents with T2D ;Primary end point(s): Change in HbA1c from baseline Visit 2 (Week 0) to Visit 7 (Week 24);Timepoint(s) of evaluation of this end point: Baseline to Week 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Change in HbA1c 2. Change in fasting plasma glucose concentration 3. Proportions of patients achieving HbA1c goals of =6.5% and <7.0% 4. Change in body weight 5. Change in fasting insulin and C-peptide 6. Change in beta-cell function (HOMA-B) and insulin sensitivity (HOMA-S) as measured by HOMA in EQW patients not taking insulin 7. Change in lipids 8. Change in blood pressure 9. Plasma exenatide concentrations 10. Proportions of patients discontinuing the study, needing rescue due to failure to maintain glycemic control, and number of rescue episodes 11. Proportions of patients reporting different injection site reactions 12. Change in body mass index (BMI) 13. Change in body weight percentile and height percentile 14. Safety and tolerability endpoints including incidence of treatment emergent AEs, antibodies to exenatide, physical examinations, laboratory measurements (clinical, chemistry/hematology), and vital sign measurements 15. Change in calcitonin, pancreatic amylase, and lipase 16. Change in TSH, free T4, prolactin, cortisol, IGF-1, and DHEAS 17. Tanner pubertal stage ;Timepoint(s) of evaluation of this end point: 1 Visit 2 to Visit 10 & interm.visit 2 Visit 2 to Visit 7, Visit 10, & interm.visit 3 Visit 7,Visit 10, and each intermediate visit 4 Visit 2 to Visit 7, Visit 10, & interm.visit 5 Visit 2 to Visit 7, Visit 10, & interm.visit 6 Visit 2 to Visit 7, Visit 10, & interm.visit 7 Visit 2 to Visit 5, Visit 7, Visit 10 8 Visit 2 to Visit 7, Visit 10, & interm.visit 9 Visit 2,Visit 7, Visit 10 & interm.visit 10 Visit 7, Visit 10 & interm.visit 11 Visit 3 to Visit 10 12,13, 14 Visit 2 to Visit 5,Visit 10, &interm.visit 15 Visit 2 to Visit 5 & Visit 10 16 Visit 2 to Visit 5,Visit 7,&Visit 10 17 Visit 2, Visit 5, Visit 7, Visit 9, & Visit 10 | — |
Countries
Bulgaria, Hungary, Israel, Kuwait, Mexico, Ukraine, United States
Contacts
Public ContactAstraZeneca Information Center
AstraZeneca
Outcome results
None listed