Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0000711
- Lead Sponsor
- Eli Lilly Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Terminated
- Sex
- All
- Target Recruitment
- 10
[1] 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
[2] have a history of type 2 diabetes with the original diagnosis based on at least
one ADA diagnostic criteria (Section 7.1.1)
[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 naive 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
Patients will be excluded from the study if they meet any of the following criteria:
[11] are the children or immediate family members of either Lilly or Amylin
employees or investigator site personnel directly affiliated with this study.
Immediate family is defined as a spouse, parent, child, or sibling, whether
biological or legally adopted
[12] 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
[13] have previously been exposed to exenatide or, completed or withdrawn from
this study or any other study investigating exenatide
[14] are unwilling or unable to inject the study medication
[15] have a genetic syndrome or disorder other than diabetes known to affect
glucose tolerance
[16] have a known allergy or hypersensitivity to exenatide or excipients contained
in the agent
[17] have used an alpha-glucosidase inhibitor, a meglitinide, or pramlintide for
more than 1 week during the 3 months prior to screening
[18] currently use inhaled steroids at a dose equal to or above 1000 ?g Flovent?
(fluticasone propionate) daily
[19] have used oral steroids within the last 60 days or more than 20 days use within
the past year
[20] have used a TZD within 120 days prior to screening
[21] have used any weight loss medication(s) within 30 days of screening
[22] 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
[23] are female who is pregnant or planning to become pregnant within 6 months
of study screening
H8O-MC-GWBQ(b) Clinical Protocol Page 22
LY2148568
[24] are female who is lactating.
[25] 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)
[26] have hepatic dysfunction, defined by aspartate (AST) or alanine (ALT)
transaminase >3.0 times the upper limit of normal (ULN)
[27] 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
[28] have physical limitations that prevent participation in lifestyle intervention
[29] have admitted use of anabolic steroids within the past 60 days
[30] 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
[31] have investigator-determined significant organ system illness or condition,
including but not limited to psychiatric or developmental disorder that prevent
participation in lifestyle intervention
[32] fail to satisfy the investigator of suitability to participate for any other reason
[33] have used insulin for more than 10 weeks during the 3 months prior to
screening
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the change in HbA1c from baseline to 28 weeks of treatment
- Secondary Outcome Measures
Name Time Method proportion of patient achieving an HbA1c =7%, <7%, =6.5%, and <6.5%