Type 2 Diabetes | Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Type 2 Diabetes research study
What is the primary objective of this study?
The primary objective of this study is to test the hypothesis that glycemic control, as measured by change in hemoglobin A1c (HbA1c) from baseline to endpoint, with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients with type 2 diabetes who are naïve to antidiabetes agents, or patients who are being treated with metformin, an SU, or a combination of metformin and an SU.
Who is eligible to participate?
Inclusion Criteria-patients are eligible to be included in the study only if they meet all of the following criteria: - are a male or a female between ages 10 to 17 years, inclusive. The number of patients ≥17 years of age will be limited to no more than 10% of patients in each treatment arm - have a history of type 2 diabetes with the original diagnosis based on at least one American Diabetes Association (ADA) diagnostic criteria - have been treated with metformin, an SU, or both metformin and an SU (with or without diet and exercise), for at least 3 months or are naïve to anti-diabetes agents and being treated with diet and exercise alone. The dose of oral agent(s) should be stable for the 30 days prior to the screening visit - have fasting C-peptide >0.6 ng/mL - have HbA1c between 6.5% and 10.5%, inclusive. Disease Diagnostic Criteria-for the purposes of this study, patients with type 2 diabetes are defined by: - diagnosis of type 2 diabetes, as determined by ADA diagnostic criteria and antibody testing, documented and confirmed in the patient's medical record, which includes laboratory determinations consistent with one or more of the following in the patient's medical history - fasting blood glucose 126 mg/dL (7.0 mmol/L) - random blood glucose 200 mg/dL (11.1 mmol/L) - two-hour OGTT (Oral Glucose Tolerance Test) ≥ 200 mg/dL (11.1 mmol/L) AND one or more of the following: no antibodies to GAD65 OR no antibodies to islet cell antigen (ICA512). Exclusion Criteria-patients will be excluded from the study if they meet any of the following criteria: - have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide - are unwilling or unable to inject the study medication - currently use inhaled steroids at a dose equal to or above 1000g Flovent (fluticasone propionate) daily - have used oral steroids within the last 60 days or more than 20 days use within the past year - have used any weight loss medication(s) within 30 days of screening - have used insulin for more than 10 weeks during the 3 months prior to screening - have history of renal disease, or serum creatinine >1.6 mg/dL (141.4 µmol/L) (males) or >1.4 mg/dL (123.8 µmol/L) (females) - have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT) transaminase >3.0 times the upper limit of normal (ULN).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Type 2 Diabetes
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PlaceboSubcutaneous injection, twice a day
Drug:ExenatideSubcutaneous injection, 5 µg, twice a day
Drug:ExenatideSubcutaneous injection,10 µg, twice a day
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PlaceboSubcutaneous injection, twice a day
Exenatide 5 µgSubcutaneous injection, twice a day
Exenatide 10 µgSubcutaneous injection, twice a day
Start Date: May 30, 2008
Completed Date: May 15, 2020
Phase: Phase 3
Primary Outcome: The primary objective of this study is to test the hypothesis that glycemic control with exenatide is superior to that of placebo after 28 weeks of treatment in adolescent patients
Secondary Outcome: The secondary objectives of the study are to evaluate the difference between exenatide and placebo with respect to glycemic, weight, and safety assessments.
Study sponsors, principal investigator, and references
Lead Sponsor: AstraZeneca
Collaborator: Quintiles, Inc.