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Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes | Clinical Trials | Clareo Health

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

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

NCT00658021•AstraZeneca

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

10 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion 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

•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).

Locations (53)

Research Site

Birmingham, Alabama, United States

Research Site

Tucson, Arizona, United States

Research Site

Los Angeles, California, United States

Research Site

Montclair, California, United States

Research Site

Sacramento, California, United States

Research Site

San Diego, California, United States

Research Site

Santa Ana, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Melbourne, Florida, United States

Research Site

Miami, Florida, United States

Key Dates

Start Date

May 30, 2008

Primary Completion Date

April 18, 2019

Completion Date

April 1, 2020

Last Updated

December 1, 2020

Enrollment

122

ACTUAL participants

Conditions

Type 2 Diabetes

Interventions

Placebo

DRUG

Exenatide

DRUG

Exenatide

DRUG

Feasibility of a Tailored Online Self-compassion Intervention

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Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGPHASE2

Trial Against INtractable Type 2 Diabetes (CAPTAIN-T2D)

NCT07296484

Type 2 DiabetesCortisol Excess

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 1, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Feasibility of a Tailored Online Self-compassion Intervention

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