Health Condition 1: null- Adolescents With Type 2 Diabetes
Conditions
Interventions
Intervention1: Exenatide 5 mcg arm: Subcutaneous injection, twice a day, 5 mcg for 28 weeks
Intervention2: Exenatide 10 mcg arm: Subcutaneous injection, twice a day, 5 mcg for 4 weeks followed by 10 m
Sponsors
Eli Lilly and Company
Eligibility
Inclusion 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
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 -Have previously been exposed to exenatide or, completed or withdrawn from any study investigating exenatide.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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 patientsTimepoint: 28 Weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Exenatide 5 µg BID vs. Exenatide 10 µg BID vs. placebo to compare: the proportion of patients achieving an HbA1c at endpoint of â?¤7%, 7%, â?¤6.5% and 6.5% â?¢ body weight â?¢ fasting serum glucose.Timepoint: 28 Weeks | — |
Countries
India, Mexico, United States of America
Contacts
Public ContactAnil Seth
Eli Lilly and Company India Private Limited
Outcome results
None listed