Clinical trial NCT00658021: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes
Official title: Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents With Type 2 Diabetes.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 2 Diabetes
Keywords: diabetes
adolescents
exenatide
Astra Zeneca
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2008-04-14
Enrollment: 122
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility 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).

Primary outcomes:
measure: Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28
timeFrame: Baseline (Day 1) and Week 28
measure: Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period
timeFrame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.
Secondary outcomes:
measure: Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28
timeFrame: Weeks 0, 4, 12, 20 and 28
measure: Adjusted Change From Baseline in Body Weight Through Week 28
timeFrame: Baseline (Day 1) up to Week 28
measure: Adjusted Change From Baseline in Fasting Serum Glucose (FSG) at Week 28
timeFrame: Baseline (Day 1) and Week 28
measure: Adjusted Change From Baseline in Self-Monitored Blood Glucose (SMBG) at Week 28
timeFrame: Pre-meal and 2 hours post-meal on Baseline (Day 1) and Week 28
measure: Adjusted Change From Baseline in Fasting Serum Insulin at Week 28
timeFrame: Baseline (Day 1) and Week 28
measure: Adjusted Change From Baseline in Homeostasis Model Assessments - Beta-Cell Function (HOMA-B) and Insulin Sensitivity (HOMA-S) at Week 28
timeFrame: Baseline (Day 1) and Week 28
measure: Percentage of Participants Discontinuing the Study Due to Failure to Maintain Glycemic Control Through Week 28
timeFrame: Weeks 2, 4, 8, 12, 16, 20, 24 and 28
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Los Angeles
country: United States
facility: Research Site
state: California
city: Montclair
country: United States
facility: Research Site
state: California
city: Sacramento
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Aurora
country: United States
facility: Research Site
state: Colorado
city: Melbourne
country: United States
facility: Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Research Site
state: Florida
city: Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Pensacola
country: United States
facility: Research Site
state: Florida
city: Tallahassee
country: United States
facility: Research Site
state: Florida
city: Dalton
country: United States
facility: Research Site
state: Georgia
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Chicago
country: United States
facility: Research Site
state: Illinois
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Wichita
country: United States
facility: Research Site
state: Kansas
city: Dearborn
country: United States
facility: Research Site
state: Michigan
city: Kansas City
country: United States
facility: Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Research Site
state: Missouri
city: Reno
country: United States
facility: Research Site
state: Nevada
city: Jamaica
country: United States
facility: Research Site
state: New York
city: Greenville
country: United States
facility: Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Dallas
country: United States
facility: Research Site
state: Texas
city: San Antonio
country: United States
facility: Research Site
state: Texas
city: Spokane
country: United States
facility: Research Site
state: Washington
city: Fortaleza
country: Brazil
facility: Research Site
city: Juiz de Fora
country: Brazil
facility: Research Site
city: Santo André
country: Brazil
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Bangalore
country: India
facility: Research Site
city: Pune
country: India
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Aguascalientes
country: Mexico
facility: Research Site
city: Culiacán
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: San Juan del Rio
country: Mexico
facility: Research Site
city: Tamaupilas
country: Mexico
facility: Research Site
city: Tampico
country: Mexico
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Tomsk
country: Russian Federation
facility: Research Site
city: Ufa
country: Russian Federation
facility: Research Site
city: Moloto
country: South Africa
facility: Research Site
city: Paarl
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Verulam
country: South Africa
facility: Research Site
Study officials:
References: