A Phase 3 , Double-blind, placebo-controlled, randomized, multi center study to assess the safety and efficacay of Exenatide once weekly in adolescents with type 2 diabetes.
Study ID: STU 062016-001
Study BCB114 is a Phase 3, double-blind (controlled assessment period), placebo controlled, randomized, parallel study conducted at multiple clinical study sites. This study will assess safety and efficacy of eQW (as monotherapy and adjunctive therapy to oral antidiabetic agents and/or insulin). at least 40% and not more than 60% of the randomized patients must be females. at least 40% of patients should be recruited from areas with similar ethnicity and lifestyle to those of the european union member states. approximately 77 patients will be randomly assigned across 2 treatment groups in a 5:2 ratio to receive either subcutaneous (SC) administration of eQW 2 mg or placebo (PBo), respectively, with at least 50 patients in the exenatide and at least 20 patients in the PBo group. Group a: eQW 2 mg (52 weeks) Group B: PBo (24 weeks), eQW 2 mg (28 weeks) The study includes a 24-week, controlled assessment period, during which patients will receive study medication according to their randomized treatment group, followed by a 28-week, open-label, uncontrolled extension period in which all patients will receive eQW. in addition to receiving study medications, all patients will participate in a lifestyle intervention program encompassing diet and physical activity modifications. if patients are taking concomitant antidiabetic medication they should administer their usual concomitant antidiabetic medication therapy at approximately the same time each day throughout the study. at Visit 1 (Screening), patients will complete eligibility evaluations and screening procedures. Patients who meet eligibility requirements will be randomly assigned to a treatment group (Group a: eQW 2 mg, Group B: PBo) at Visit 2 (Week 0). at Visit 2 (Week 0), patients will complete baseline safety, efficacy, pharmacodynamic (PD), and pharmacokinetic (PK) assessments. Following baseline assessments, patients and parents/caretaker will be trained on study medication administration and the first dose of study medication will be administered. During the controlled assessment period, patients or parent/caretaker will administer study medication. Patients will return to the study site at 4- or 6-week intervals for safety, efficacy, PD, and PK assessments. on weeks with no scheduled study-site visits, patients may opt to return to the study site to have the injection procedure monitored or provided by study-site personnel. Following the 24-week controlled assessment period, all patients will enter the 28-week extension period. During the 28-week extension period, all patients will receive eQW 2 mg for 28 weeks up to Visit 10 (Week 52/end of Treatment). The patients will return to the study site at 6- or 12-week intervals for safety, efficacy, PD, and PK assessments and will complete study termination procedures at Visit 11 (Week 62/Study Termination). all patients will have Visit 11 (Week 62/Study Termination) which is a follow-up visit occurring 10 weeks after the last dose administration at Visit 10 (Week 52). Following Visit 11 (Week 62/Study Termination), patients whose height increase is at least 5 mm between Visit 8 (Week 28) and Visit 11 (Week 62/Study Termination) will participate in an extended Safety Follow-up Period. Patients who discontinue study medication prior to Visit 10 (Week 52) will also participate in the extended Safety Follow-up Period, unless they have a height increase of less than 5 mm over a 6-month interval at study site visits prior to discontinuation of study medication. Patients who do not have height assessments at study-site visits over a 6-month interval prior to discontinuation of study medication will enter the extended Safety Follow-up Period. The extended Safety Follow-up Period will continue for up to 3 years or until the increase in height between two 6 month interval visits is less than 5 mm (whichever comes first). no study medication will be administered during the extended Safety Follow-up Period.
For inclusion in the study patients should fulfil the following criteria: 1. Is a child or an adolescent of 10 to <18 years old, at Visit 1 (Screening) 2. Has been diagnosed with type 2 diabetes mellitus per American Diabetes Association diagnostic criteria 3. HbA1c of 6.5% to 11.0%, inclusive, in patients not taking insulin/SU, and of 6.5% to 12.0%, inclusive, in patients taking insulin/SU, at Visit 1 (Screening) 4. Has a C-peptide of >0.6 ng/L 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 <280 mg/dL (15.5 mmol/L) at Visit 1 (Screening) 7. Either is not treated with or has been on a stable treatment regimen with any of the following medications for a minimum of 1 month prior to Visit 1 (Screening): a. Oral contraceptives (female patients) b. Antihypertensive agents c. Lipid-lowering agents d. Thyroid replacement therapy e. Antidepressant agents 8. Is male, or is female and meets all the following criteria: a. Not breastfeeding b. Negative pregnancy test result (human chorionic gonadotropin, beta subunit [beta hCG]) at Visit 1 (Screening) c. If of childbearing potential, must practice and be willing to continue to practice appropriate birth control (defined as at least 1 method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives, some intrauterine contraceptive devices, sexual abstinence, tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study and must not be planning to conceive 9. Has clinical laboratory test values (clinical chemistry, hematology, and urinalysis) judged as not clinically significant by the Investigator at Visit 1 (Screening) 10. Has physical examination and ECG results deemed not clinically significant by the Investigator at Visit 2 (Week 0) 11. Both patient and parent/caretaker are able to read, understand, and sign the Informed Consent Form (ICF) and Child Assent Form and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the Investigator, and understand and comply with protocol requirements 12. Both patient and parent/caretaker are able to read and understand the lifestyle modification program and the parent/caretaker is willing to assist the patient[Single Quote]s adherence to the lifestyle modification program
- Cancer Related
- Healthy Volunteers
- UT Southwestern Principal Investigator
- Olga Theresa Gupta
ASTRAZENECA PHARMACEUTICALS LP
Other Endocrine System