Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes

AstraZeneca

Status and phase: Completed; Phase 3

Conditions: Type 2 Diabetes

Treatments: Drug: Exenatide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00658021

H8O-MC-GWBQ (Other Identifier)

D5550C00002

Details and patient eligibility

About

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

Enrollment: 122 patients

Sex: All

Ages: 10 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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122 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subcutaneous injection, twice a day

Treatment:

Drug: Placebo

Exenatide 5 µg

Experimental group

Description:

Subcutaneous injection, twice a day

Treatment:

Drug: Exenatide

Drug: Exenatide

Exenatide 10 µg

Experimental group

Description:

Subcutaneous injection, twice a day

Treatment:

Drug: Exenatide

Drug: Exenatide