Clinical Trial Details

NCT ID: NCT00658021
Date Last Changed: October 16, 2017

Overview

Research Study Summary

Patients are needed to participate in a clinical research study evaluating placebo and exenatide for the treatment of Type 2 Diabetes

Research Study Title

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

Purpose

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.

To Learn more

Recruitment Details

Phase
3
Gender
All
Age
10 to 17 Years
Overall Status
Recruiting
Lead Sponsor
AstraZeneca
Duration
123 Months
Facility Type
N/A
Compensation

Eligibility

All ages 10 Years to 17 Years

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).

Site Locations (20)

Country State City Zip Facility and Contact
United States Alabama Birmingham 35233 Research Site
United States California Montclair 91763 Research Site
United States Florida Miami Lakes 33014 Research Site
United States Florida Miami 33144 Research Site
United States Missouri Kansas City 64108 Research Site
United States New York Jamaica 11432 Research Site
United States New York Mineola 11501 Research Site
United States Texas Dallas 75225 Research Site
United States Utah Salt Lake City 84107 Research Site
Brazil Brasília 71625-009 Research Site
Brazil Caxias do Sul 95070-560 Research Site
Brazil Goiânia 74110-010 Research Site
Brazil Juiz de Fora 36025-330 Research Site
Brazil Santo André 09030-010 Research Site
Mexico Guadalajara 44650 Research Site
Mexico Monterrey 64710 Research Site
Mexico Puebla 72190 Research Site
Mexico San Juan del Rio 76800 Research Site
South Africa Paarl 7626 Research Site
South Africa Verulam 4345 Research Site

Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
E-mail:

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