Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AstraZeneca
With
Quintiles, Inc.
Age
10–17
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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).
You may not be if
have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide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).
Clareo Health | Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
