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

AstraZeneca122 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

122

Conditions

Type 2 Diabetes

Interventions

PlaceboDRUG

Subcutaneous injection, twice a day

ExenatideDRUG

Subcutaneous injection, 5 µg, twice a day

ExenatideDRUG

Subcutaneous injection,10 µg, twice a day

Eligibility

Sex: ALLMin age: 10 YearsMax age: 17 Years

Medical Language ↔ Plain English

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).

Locations (53)

Outcomes

Primary Outcomes

Adjusted Change From Baseline in Glycated Hemoglobin A1c (HbA1c) at Week 28

Change from baseline in HbA1c is reported as adjusted least square (LS) mean values at Week 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A mixed model with repeated measures (MMRM) analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

Time frame: Baseline (Day 1) and Week 28

Number of Participants With Post-Treatment Adverse Events of Special Interest (AESI) During Safety Follow-up Period

Post-treatment adverse events (AEs) were defined as AEs that started or worsened during the off-treatment period (Safety Follow-up Period), which was defined as the day after the Week 28/early discontinuation (ED) visit to the date of completion of the Safety Follow-up Period. The AESIs recorded were as follows: hematological malignancies, thyroid neoplasms, pancreas neoplasms, aplastic anemia, pancreatitis, pregnancy and pregnancy outcomes (including congenital anomalies).

Time frame: From 1 day after the Week 28/ED visit to 3 years after Week 28/ED visit.

Secondary Outcomes

Percentage of Participants Achieving HbA1c Goals of < 7%, <= 6.5%, and < 6.5% Through Week 28

The percentage of participants achieving HbA1c goals of \< 7%, \<= 6.5%, and \< 6.5% through Week 28 were compared between treatments using the Cochran-Mantel-Haenszel (CMH) procedure, in which screening HbA1c strata and background diabetes therapy strata served as the stratification factors. The CMH analysis excluded measurements after initiation of rescue medication and study drug discontinuation with missing data treated as non-responder.

Time frame: Weeks 0, 4, 12, 20 and 28

Adjusted Change From Baseline in Body Weight Through Week 28

Change from baseline in body weight is reported as adjusted LS mean values at Weeks 4, 12, 20 and 28. Baseline is defined as the last non-missing assessment (scheduled or unscheduled) on or prior to the first dose of study medication. A MMRM analysis was performed, excluding measurements after initiation of rescue medication and study drug discontinuation.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

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

...and 43 more locations