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

NCT ID: NCT00658021

Last Updated: 2020-12-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 122 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-30
• Study Completion Date: 2020-04-01

Brief 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

Conditions

Type 2 Diabetes

Keywords

diabetes; adolescents; exenatide; Astra Zeneca

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Subcutaneous injection, twice a day

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Subcutaneous injection, twice a day

Exenatide 5 µg

Subcutaneous injection, twice a day

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Subcutaneous injection, 5 µg, twice a day

Exenatide 10 µg

Subcutaneous injection, twice a day

Group Type: EXPERIMENTAL

Exenatide

Intervention Type: DRUG

Subcutaneous injection,10 µg, twice a day

Interventions

Placebo

Subcutaneous injection, twice a day

Intervention Type: DRUG

Exenatide

Subcutaneous injection, 5 µg, twice a day

Intervention Type: DRUG

Exenatide

Subcutaneous injection,10 µg, twice a day

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Quintiles, Inc.

INDUSTRY

Sponsor Role: collaborator

AstraZeneca

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

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Santa Ana, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Melbourne, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

Research Site

Orlando, Florida, United States

Research Site

Pensacola, Florida, United States

Research Site

Tallahassee, Florida, United States

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Dalton, Georgia, United States

Research Site

Chicago, Illinois, United States

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Chicago, Illinois, United States

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Indianapolis, Indiana, United States

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Wichita, Kansas, United States

Research Site

Dearborn, Michigan, United States

Research Site

Kansas City, Missouri, United States

Research Site

St Louis, Missouri, United States

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Reno, Nevada, United States

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Jamaica, New York, United States

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Greenville, North Carolina, United States

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Raleigh, North Carolina, United States

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Oklahoma City, Oklahoma, United States

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Memphis, Tennessee, United States

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Dallas, Texas, United States

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San Antonio, Texas, United States

Research Site

Spokane, Washington, United States

Research Site

Fortaleza, , Brazil

Research Site

Juiz de Fora, , Brazil

Research Site

Santo André, , Brazil

Research Site

Ahmedabad, , India

Research Site

Bangalore, , India

Research Site

Pune, , India

Research Site

Aguascalientes, , Mexico

Research Site

Culiacán, , Mexico

Research Site

Guadalajara, , Mexico

Research Site

Monterrey, , Mexico

Research Site

San Juan del Río, , Mexico

Research Site

Tamaupilas, , Mexico

Research Site

Tampico, , Mexico

Research Site

Quezon City, , Philippines

Research Site

Moscow, , Russia

Research Site

Tomsk, , Russia

Research Site

Ufa, , Russia

Research Site

Moloto South, , South Africa

Research Site

Paarl, , South Africa

Research Site

Pretoria, , South Africa

Research Site

Verulam, , South Africa

Research Site

Seoul, , South Korea

Countries

China; Puerto Rico; United States; Brazil; India; Mexico; Philippines; Russia; South Africa; South Korea

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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Clinical\_Study\_Protocol\_redacted

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5550C00002&attachmentIdentifier=6cfc1d5f-a256-4d8b-8b54-6944c1993205&fileName=D5550C00002_Statistical_Analysis_Plan.pdf&versionIdentifier=

Statistical Analysis Plan\_redacted

Other Identifiers

H8O-MC-GWBQ

Identifier Type: OTHER

Identifier Source: secondary_id

D5550C00002

Identifier Type: -

Identifier Source: org_study_id