CTRI/2018/02/011717尚未招募3 期
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes
Amylin LLC a wholly owned subsidiary of AstraZeneca0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients are eligible to be included in the study only if they meet all of the following criteria:
- •[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 American Diabetes Association (ADA) diagnostic criteria
- •[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 patientâ??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.
- •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 patientâ??s medical record,
- •which includes laboratory determinations consistent with one or more of the
- •following in the patientâ??s medical history:
- •I)fasting blood glucose ï?³126 mg/dL (7.0 mmol/L)
- •ii) random blood glucose ï?³200 mg/dL (11.1 mmol/L)
- •iii) two-hour OGTT (Oral Glucose Tolerance Test) ï?³200 mg/dL (11.1
- •AND one or more of the following:
- •I) no antibodies to GAD65
- •ii) no antibodies to islet cell antigen (ICA512)
排除标准
- •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 Amylin, Bristol- Myers Squibb, or AstraZeneca 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 ï?g Floventï?? (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
- •[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
研究者
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