Investigation of Exenatide inAdolescents with Type 2 Diabetes

• Conditions: Treatment of Type 2 diabetes mellitus; MedDRA version: 14.1Level: LLTClassification code 10012594Term: DiabetesSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]

• Registration Number: EUCTR2011-005196-16-Outside-EU/EEA
• Lead Sponsor: Amylin Pharmaceuticals, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-24
• Last Update Posted: 31 July 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 195

Inclusion Criteria

Patients are eligible to be included in the study only if they meet all of the following criteria:
[1] between ages 10 to 17 years, inclusive.
[2] have a history of type 2 diabetes
[3] 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
[4] have fasting C-peptide >0.6 ng/mL
[5] have no antibodies to glutamic acid decarboxylase (GAD65) or islet cell antigen (ICA512)
[6] have HbA1c between 6.5% and 10.5%, inclusive
[7] present an appropriately signed assent form
[8] a parent or adult guardian agrees in writing to participate in the patient’s treatment by signing a consent form
[9] both the patient and parent or responsible adult guardian are able to understand and comply with a lifestyle modification program
[10] the investigator determines that patient and parent or responsible adult guardian are able to fully participate in and likely to complete the trial.
Are the trial subjects under 18? yes
Number of subjects for this age range: 195
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients will be excluded from the study if they meet any of the following criteria:
[1] have received treatment within the last 60 days with a drug that has not received regulatory approval for any indication at the time of study entry
[2] have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide
[3] are unwilling or unable to inject the study medication
[4] have a genetic syndrome or disorder other than diabetes known to affect glucose tolerance
[5] have a known allergy or hypersensitivity to exenatide or excipients contained in the agent
[6] have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for
more than 1 week during the 3 months prior to screening
[7] currently use inhaled steroids at a dose equal to or above 1000ug Flovent (fluticasone propionate) daily
[8] have used oral steroids within the last 60 days or more than 20 days use within
the past year
[9] have used a TZD within 120 days prior to screening
[10] have used any weight loss medication(s) within 30 days of screening
[11] are sexually active female of childbearing potential who is unwilling to appropriately use TWO methods of birth control for the duration of the study
[12] are female who is pregnant or planning to become pregnant within 6 months of study screening
[13] are female who is lactating.
[14] have history of renal disease
[15] have hepatic dysfunction,
[16] have had at least 1 episode of diabetic ketoacidosis after receiving antidiabetes medication. A history of diabetic ketoacidosis at the time of diagnosis will not be an exclusion criterion
[17] have physical limitations that prevent participation in lifestyle intervention
[18] have admitted use of anabolic steroids within the past 60 days
[19] have an active or untreated malignancy, or have been in remission from clinically significant malignancy (other than in situ carcinomas of the cervix) for less than 5 years
[20] have investigator-determined significant organ system illness or condition,
including but not limited to psychiatric or developmental disorder that prevent participation in lifestyle intervention
[21] fail to satisfy the investigator of suitability to participate for any other reason
[22] have used insulin for more than 10 weeks during the 3 months prior to screening

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to test the hypothesis that glycemic control, with exenatide is superior, to that of placebo after 28 weeks of treatment in adolescent patients.;Secondary Objective: The main secondary objectives of the study are to compare exenatide 5 µg twice daily and exenatide 10 µg twice daily versus each other and versus placebo with regards to:<br>? the proportion of patients achieving an HbA1c at endpoint of <7%,=6.5%, and <6.5%<br>? body weight<br>? fasting serum glucose <br>? self-monitored blood glucose ;Primary end point(s): to test the hypothesis that glycemic control, with exenatide is superior, to that of placebo after 28 weeks of treatment in adolescent patients;Timepoint(s) of evaluation of this end point: 28 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The following main secondary efficacy measures will be collected as per the Study Schedule.<br>? proportion of patient achieving an HbA1c <7%, =6.5%, and <6.5%<br>? body weight<br>? Fasting Serum Glucose<br>? Self monitoring blood glucose ;Timepoint(s) of evaluation of this end point: 28 weeks