CTRI/2012/01/002337CompletedPhase 3
Safety and Efficacy of Exenatide as Monotherapy andAdjunctive Therapy to Oral Antidiabetic Agents inAdolescents with Type 2 Diabetes
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Eli Lilly and Company
- Enrollment
- 195
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •Are between ages 10 to 17 years, inclusive.
- •-Have a history of type 2 diabetes.
- •-Have no antibodies to glutamic decarboxylase (GAD65) or islet cell (ICA512).
- •-Have been treated with Met, an SU, or both Met and SU (with or without diet and exercise), for at least 3 months or are naïve to antidiabetic agents (with diet and exercise). The dose of oral agent(s) should be stable for the 30 days prior to the screening visit.
- •-Have HbA1c between 6.5% and 10.5%, inclusive.
- •-Present an appropriately signed assent form.
- •-A parent or adult guardian agrees in writing to participate in the patient(s) treatment by signing a consent form.
- •-Both the patient and parent or responsible adult guardian are able to understand and comply with a lifestyle modification program.
Exclusion Criteria
- •-Received any investigational drug or has participated in any type of clinical trial within 60 days prior to screening.
- •-Have previously been exposed to exenatide or, completed or withdrawn from any study investigating exenatide.
- •-Are unwilling or unable to inject the study medication.
- •-Have a genetic syndrome or disorder other than diabetes known to affect glucose tolerance.
- •-Have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for more than 1 week during the 3 months prior to screening.
- •-Currently use inhaled steroids at a dose equal to or above 1000 μg 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 a TZD within 120 days prior to screening.
- •-Have used any weight loss medication(s) within 30 days of screening.
- •-Are sexually active female of childbearing potential who is unwilling to appropriately use TWO methods of birth control (for example, use of oral contraceptives; condoms with contraceptive foam; or abstinence) for the duration of the study.
- •-Are female who is pregnant or planning to become pregnant within 6 months of study screening.
- •-Are female who is lactating.
- •-Have had at least one episode of diabetic ketoacidosis (DKA) after receiving antidiabetes medication. A history of DKA at the time of diagnosis will not be an exclusion criterion.
- •-Have physical limitations that prevent participation in lifestyle intervention.
- •-Have admitted use of anabolic steroids within the past 60 days.
- •-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.
- •-Have used insulin for more than 10 weeks during the 3 months prior to screening.
Investigators
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