EUCTR2011-005196-16-Outside-EU/EEA进行中（未招募）不适用
Safety and Efficacy of Exenatide as Monotherapy and Adjunctive Therapy to Oral Antidiabetic Agents in Adolescents with Type 2 Diabetes - GWBQ
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 195
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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- •[2] have previously been exposed to exenatide or, completed or withdrawn from this study or any other study investigating exenatide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
研究者
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