EUCTR2008-003843-36-GB进行中（未招募）不适用
A Randomized Trial Comparing Exenatide with Placebo in Subjects with Type 2 Diabetes on Insulin Glargine With or Without Oral Antihyperglycemic Medications - GWCO
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
- 260
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
- •[1] Have T2DM
- •[2] Are at least 18 years of age
- •[3] Have been taking basal insulin glargine at a dose of =20 units/day for at least 3 months prior to Visit 1
- •[4] Have been receiving glargine alone or in combination with one of the following OAM regimens for the 3 months prior to Visit 1:metformin,pioglitazone, a combination of metformin and a pioglitazone at a stable dose for 6 weeks prior to Visit 1 and do not meet exclusion criteria 11.
- •[5] Have an A1C =7.1% and =10.5%.
- •[6] Have a body mass index (BMI) =45 kg/m2.
- •[7] Show no evidence of cardiovascular disease as determined by a normal electrocardiogram (ECG)
- •[8] Have a history of stable body weight
- •[9] Liver enzyme tests (ALT, AST) are not greater than 1.5 times the upper limit of the reference range
- •[10] Are female subjects with serum creatinine level =1.4 mg/dL or male
- •subjects with serum creatinine level =1.5 mg/dL.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •[11] Are currently taking a dose or combination of OAM that is not allowed with concurrent use of insulin glargine per local product label
- •[12] Have taken any glucose-lowering medications not included in
- •Inclusion Criteria [3] and [4] in the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening.
- •[13] Have taken any insulin other than glargine within the 3 months prior to Visit 1 for more than 1 week or within 1 month of screening
- •[14] Have had more than one episode of major hypoglycemia, within 6 months prior to Visit 1
- •[15] Are pregnant or intend to become pregnant during the course of the study or are sexually active women of childbearing potential not actively practicing birth control by a method determined by the investigator to be medically acceptable.
- •[16] Women who are breastfeeding.
- •[17] presence of clinically significant hematologic, oncologic, renal, cardiac, hepatic,
- •gastrointestinal disease, or any other serious disease
- •[18] Have a history of renal transplantation or receiving dialysis
- •[19] Are subjects with a malignancy (see protocol for specifics)
- •[20] Have contraindication or known hypersensitivity or allergy to exenatide or to any of the product components
- •[21] Have used a drug for weight loss within 3 months prior to Visit 1 for more than 1
- •week or within 1 month of screening
- •[22] Are currently on a supervised weight-loss program
- •[23] Have had a blood transfusion or severe blood loss within 3 months prior to Visit 1 or have known hemoglobinopathy, hemolytic anemia, or sickle cell anemia, or any other condition known to interfere with the A1C methodology.
- •[24] Are receiving chronic systemic glucocorticoid therapy or have received such therapy within the 8 weeks immediately preceding Visit 1.
- •[25] Have an irregular sleep/wake cycle
- •[26] Have any other condition that renders the subject unable to understand the
- •nature, scope, and possible consequences of the study,
- •[27] Have received treatment within 30 days before Visit 1 with a drug that has not received regulatory approval for any indication at the time of study entry.
- •[28] Are investigator site personnel directly affiliated with this study and/or their immediate families.
- •[29] Are employed by Lilly or Amylin Pharmaceuticals, Inc.
- •[30] Have previously completed or withdrawn from this study after signing
- •[31] If on metformin and have contraindication to metformin use
- •[32] If on metformin, have had a radiologic contrast study performed within 48 hours prior to Visit 1.
- •[33] If on pioglitazone, have a contraindication to pioglitazone including NYHA Class II-IV CHF or are on a dose of pioglitazone that is contraindicated with insulin in that country.
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